C.02.001. [Repealed, SOR/97-12, s. 5.1]

C.02.002. In this Division,

“drug”[Repealed, SOR/97-12, s. 6]

“importer”[Repealed, SOR/97-12, s. 6]

“medical gas” means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)

“packaging material” includes a label; (matériel d’emballage)

“produce”[Repealed, SOR/97-12, s. 6]

“quality control department” means a quality control department referred to in section C.02.013; (service du contrôle de la qualité)

“specifications” means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

(a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,

(b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and

(c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)

SOR/82-524, s. 3; SOR/85-754, s. 1; SOR/89-174, s. 1; SOR/97-12, s. 6.

C.02.002.1. This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.

SOR/2004-282, s. 3.

C.02.003. No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

SOR/82-524, s. 3; SOR/97-12, s. 7; SOR/2000-120, s. 8.

C.02.004. The premises in which a lot or batch of a drug is fabricated or packaged/labelled shall be designed, constructed and maintained in a manner that

(a) permits the operations therein to be performed under clean, sanitary and orderly conditions;

(b) permits the effective cleaning of all surfaces therein; and

(c) prevents the contamination of the drug and the addition of extraneous material to the drug.

SOR/82-524, s. 3; SOR/97-12, s. 8.

C.02.005. The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that

(a) permits the effective cleaning of its surfaces;

(b) prevents the contamination of the drug and the addition of extraneous material to the drug; and

(c) permits it to function in accordance with its intended use.

SOR/82-524, s. 3; SOR/97-12, s. 9.

C.02.006. Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Director considers satisfactory in the interests of the health of the consumer or purchaser.

SOR/82-524, s. 3; SOR/85-754, s. 2; SOR/97-12, s. 52.

C.02.007. (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel.

(2) The sanitation program referred to in subsection (1) shall include

(a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labelling; and

(b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs.

SOR/82-524, s. 3; SOR/97-12, ss. 10, 53.

C.02.008. (1) Every person who fabricates or packages/labels a drug shall have, in writing, minimum requirements for the health and the hygienic behaviour and clothing of personnel to ensure the clean and sanitary fabrication and packaging/labelling of the drug.

(2) No person shall have access to any area where a drug is exposed during its fabrication or packaging/labelling if the person

(a) is affected with or is a carrier of a disease in a communicable form; or

(b) has an open lesion on any exposed surface of the body.

SOR/82-524, s. 3; SOR/97-12, s. 11.

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) Where any property of a raw material is subject to change on storage, no lot or batch of that raw material shall be used in the fabrication of a drug after its storage unless the raw material is retested after an appropriate interval and complies with its specifications for that property.

(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 Director 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.

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 Director 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 Director, 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.

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.

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 designed 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) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsection (2) in respect of that drug.

(4) If a drug is fabricated or packaged/labelled in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of the drug is not required to comply with the requirements of subsection (2) in respect of that activity for that drug if

(a) the address of the building is set out in that person’s establishment licence; and

(b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.

SOR/82-524, s. 3; SOR/97-12, s. 13; SOR/2000-120, s. 9; SOR/2002-368, s. 9.

C.02.013. (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall have on their premises in Canada a quality control department that is supervised by personnel described in section C.02.006.

(2) The quality control department referred to in subsection (1) 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.

C.02.014. (1) No lot or batch of drug shall be made available for sale unless the sale of that lot or batch is approved by the person in charge of the quality control department.

(2) A drug that is returned to the fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer thereof shall not be made available for further sale unless the sale of that drug is approved by the person in charge of the quality control department.

(3) No lot or batch of raw material or of packaging/labelling material shall be used in the fabrication or packaging/labelling of a drug unless the material is approved for that use by the person in charge of the quality control department.

(4) No lot or batch of a drug shall be reprocessed without the approval of the person in charge of the quality control department.

SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/97-12, ss. 14, 55.

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 control department shall cause to be investigated every complaint on quality that is received and cause corrective action to be taken where necessary.

(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.

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 Director 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).

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 Director 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 Director,

(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).

C.02.018. (1) Each lot or batch of a drug shall, prior to its availability for sale, be tested against the specifications for that drug.

(2) No lot or batch of a drug shall be available 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.

C.02.019. (1) Subject to subsections (3) and (4), in the case of a packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer, the testing referred to in section C.02.018 shall be performed on a sample taken

(a) after receipt of each lot or batch of the drug on the premises in Canada of the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of the drug; or

(b) subject to subsection (2), before receipt of each lot or batch of the drug on the premises described in paragraph (a), if

(i) the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer

(A) has evidence satisfactory to the Director to demonstrate that drugs sold to him by the vendor of that lot or batch of the drug are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and

(B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Director, and

(ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

(2) Where the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of a drug receives a lot or batch of the drug on their premises in Canada, and the useful life of the drug is more than 30 days, the lot or batch shall be tested for identity, and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.

(3) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsections (1) and (2) in respect of that drug.

(4) If a drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of that drug is not required to comply with the requirements of subsections (1) and (2) in respect of that drug if

(a) the address of the building is set out in that person’s establishment licence; and

(b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.

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.

C.02.020. (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain on their premises in Canada, for each drug sold,

(a) master production documents for the drug;

(b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored 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 are in compliance with the requirements of this Division;

(d) evidence establishing the period of time during which the drug in the container in which it is sold will meet the specifications for that drug; and

(e) adequate evidence of the testing referred to in section C.02.018.

(2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Director, on request, the results of testing performed on raw materials and packaging/labelling material for each lot or batch of a drug sold.

(3) Every fabricator shall maintain on his premises

(a) the written specifications for the raw material; and

(b) adequate evidence of the testing of the raw materials referred to in section C.02.009.

(4) Every person who packages a drug shall maintain on his premises

(a) the written specifications for the packaging material; and

(b) adequate evidence of the packaging material examination or testing referred to in section C.02.016.

(5) Every fabricator shall maintain on their premises in Canada

(a) detailed plans and specifications of each building in Canada at which they fabricate, package/label or test; and

(b) a description of the design and construction of those buildings.

(6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada details of the personnel employed to supervise the fabrication, packaging/labelling and testing, including each 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.

C.02.021. (1) Subject to subsection (2), all records and evidence on the fabrication, packaging/labelling, testing and storage of a drug that are required to be maintained under this Division shall be retained for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the person’s establishment licence.

(2) All records and evidence on the testing of raw materials and packaging/labelling materials that are required to be maintained under this Division shall be retained for a period of at least five years after the materials were last used in the fabrication or packaging/labelling of a drug, unless otherwise specified in the person’s establishment licence.

SOR/82-524, s. 3; SOR/89-174, s. 8(F); SOR/92-654, s. 6; SOR/97-12, s. 18.

C.02.022. Every distributor referred to in section C.01A.003, wholesaler and importer of a drug shall retain records of the sale of each lot or batch of the drug, which enable them to recall the lot or batch from the market, for a period of at least one year after the expiration date of that lot or batch, unless otherwise specified in their establishment licence.

SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18.

C.02.023. (1) On receipt of a complaint respecting the quality of a drug, every distributor referred to in paragraph C.01A.003(b) and importer of the drug shall make a record of the complaint and of its investigation and retain the record for a period of at least one year after the expiration date of the lot or batch of that drug, unless otherwise specified in their establishment licence.

(2) On receipt of any information respecting the quality or hazards of a drug, every distributor referred to in paragraph C.01A.003(b) and importer of the drug shall make a record of the information and retain it for a period of at least one year after the expiration date of the lot or batch of that drug, unless otherwise specified in their establishment licence.

SOR/82-524, s. 3; SOR/92-654, s. 7; SOR/97-12, s. 18.

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.

C.02.025. (1) Every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall retain in Canada a sample of each lot or batch of the packaged/labelled drug for a period of at least one year after the expiration date on the label of the drug, unless otherwise specified in the distributor’s or importer’s establishment licence.

(2) The fabricator shall retain a sample of each lot or batch of raw materials used in the fabrication of a drug for a period of at least two years after the materials were last used in the fabrication of the drug, unless otherwise specified in the fabricator’s establishment licence.

SOR/82-524, s. 3; SOR/89-174, s. 4(F); SOR/92-654, s. 8; SOR/97-12, s. 20.

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.

C.02.027. Every distributor referred to in paragraph C.01A.003(b) and importer shall establish the period of time during which each drug in the package in which it is sold will comply with the specifications.

SOR/82-524, s. 3; SOR/97-12, s. 58.

C.02.028. Every distributor referred to in paragraph C.01A.003(b) and importer 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.

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.

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.

C.03.001. In this Division,

“drug” means a drug listed in Schedule C to the Act that is in dosage form, or a drug that is a bulk process intermediate that can be used in the preparation of a drug listed in Schedule C to the Act that is of biological origin; (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.

C.03.001.1 No distributor referred to in paragraph C.01A.003(b) or importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with this Division.

SOR/97-12, s. 23.

C.03.002. to C.03.005. [Repealed, SOR/97-12, s. 24]

C.03.006. [Repealed, SOR/97-12, s. 67]

C.03.007. to C.03.011 [Repealed, SOR/97-12, s. 26]

C.03.012. On written request from the Director, every fabricator, packager/labeller, tester, distributor referred to in paragraph C.01A.003(b) and importer of a drug shall submit protocols of tests together with samples of any lot or master lot of the drug before it is sold, and no person shall sell a lot of which the protocol or sample fails to meet the requirements of these Regulations.

SOR/97-12, s. 27.

C.03.013. No person shall fabricate or import a drug that is derived from animal tissue unless the tissue is obtained from a healthy animal free from infectious disease.

SOR/97-12, s. 27.

C.03.014. (1) Section C.01.004 does not apply to a drug.

(2) and (3) [Repealed, SOR/97-12, s. 28]

SOR/79-236, s. 1; SOR/93-202, s. 15; SOR/97-12, s. 28.

C.03.015. Every package of a drug listed or described in Schedule F in the Regulations, other than

(a) a drug sold to a drug fabricator,

(b) a drug dispensed pursuant to a prescription,

(c) a radiopharmaceutical as defined in section C.03.201, or

(d) a component or kit as defined in section C.03.205,

shall carry the symbol Pr on the upper left quarter of the principal display panel of both its inner and outer labels or, in the case of a single dose container, on the upper left quarter of its outer label.

SOR/80-543, s. 9; SOR/97-12, s. 61; SOR/2001-181, s. 4.

C.03.030. to C.03.045. [Repealed, SOR/81-335, s. 2]

C.03.201. In these Regulations, “radiopharmaceutical” means a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons.

SOR/97-12, s. 29.

C.03.202. (1) Every package containing a radiopharmaceutical, other than a radionuclide generator, shall carry,

(a) on both the inner and the outer labels,

(i) the proper name of the drug, which proper name, where there is a brand name, shall immediately precede or follow the brand name,

(ii) the name of the distributor referred to in paragraph C.01A.003(b), and

(iii) the lot number; and

(b) on the outer label

(i) the address of the distributor referred to in paragraph C.01A.003(b),

(ii) the standard that the drug professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act,

(iii) a statement of the pharmaceutical form or the route of administration of the drug,

(iv) a statement of the recommended use and the recommended radioactivity to be administered for that use, or a reference to an accompanying package insert that shows such information,

(v) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof,

(vi) the radiation warning symbol required by the Atomic Energy Control Regulations and the statement “Caution—Radioactive Material” “Attention—Produit radioactif”,

(vii) the names and a statement of the amounts of any preservatives or stabilizing agents contained in the drug,

(viii) the names and a statement of the amounts of all other non-radioactive contents of the drug,

(ix) a statement of the total radioactivity content of the drug including overfill,

(x) a statement of the total volume of the drug including overfill, except where its contents are entirely in gaseous, capsule or lyophilized form,

(xi) a statement of the concentration of radioactive material in the drug expressed as

(A) units of radioactivity per capsule or

(B) units of radioactivity per unit volume,

except where the contents of the drug are entirely in gaseous or lyophilized form,

(xii) a statement of the specific activity of the drug expressed as units of radioactivity per unit weight of carrier present or the statement “carrier-free” or “sans entraîneur”, whichever is applicable,

(xiii) a statement of the reference time in respect of the radioactivity values mentioned in subparagraphs (ix), (xi) and (xii), the name of the month being written or designated by letter abbreviation,

(xiv) a statement of the recommended useful life or the date after which the drug is not recommended for use, the name of the month being written or designated by letter abbreviation, and

(xv) a statement of the special storage requirements with reference to temperature and light.

(2) [Repealed, SOR/2001-203, s. 2]

(3) Subparagraph (1)(b)(viii) of this section does not apply where the information referred to in that subparagraph is shown on a package insert that accompanies the drug.

(4) Section C.01.005 does not apply to a radiopharmaceutical.

SOR/79-236, s. 2; SOR/93-202, s. 16; SOR/97-12, ss. 54, 58, 62; SOR/2001-203, s. 2.

C.03.203. (1) Every radionuclide generator shall carry on the inner label

(a) the proper name of the radionuclide generator, which proper name, where there is a brand name, shall immediately precede or follow the brand name;

(b) the name and address of the distributor referred to in paragraph C.01A.003(b);

(c) the lot number;

(d) the standard that the radionuclide generator professes to meet, if that standard is referred to in any publication mentioned in Schedule B to the Act;

(e) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;

(f) the radiation warning symbol required by the Atomic Energy Control Regulations and the statement “Caution—Radioactive Material” “Attention—Produit radioactif”;

(g) a statement of the total parent radioactivity contained in the radionuclide generator;

(h) a statement of the hour and date at which the radioactivity value mentioned in paragraph (g) is valid, the name of the month being written or designated by letter abbreviation;

(i) a statement of the recommended useful life or the date after which the radionuclide generator is not recommended for use, the name of the month being written or designated by letter abbreviation;

(j) a statement of the recommended useful life of the drug after removal from the radionuclide generator;

(k) a statement of special storage requirements with reference to temperature or shielding;

(l) complete directions for use or a reference to an accompanying package insert that sets out such directions; and

(m) a statement cautioning against the dismantling of the radionuclide generator.

(2) Paragraphs (1)(i) and (j) of this section do not apply where the information referred to in those subparagraphs is shown on a package insert that accompanies the radionuclide generator.

SOR/79-236, s. 3; SOR/93-202, s. 17; SOR/97-12, ss. 54, 58, 62.

C.03.204. (1) No person shall sell a drug containing technetium-99m at any time during the useful life of the drug if the drug also contains a radionuclidic impurity mentioned in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication mentioned in item 7 of Schedule B to the Act, in an amount greater than that shown in the monograph.

(2) No person shall sell a radionuclide generator from which can be removed a drug that contains technetium-99m, at any time during the useful life of the drug, if the drug also contains a radionuclidic impurity mentioned in the monograph for Sodium Pertechnetate Tc-99m Injection referred to in the publication mentioned in item 7 of Schedule B to the Act, in an amount greater than that shown in the monograph.

SOR/97-12, s. 30.

C.03.205. For the purposes of sections C.03.206 to C.03.209,

“component” means

(a) a unit of a drug, other than a radionuclide, separately packaged in a kit for use in the preparation of a radiopharmaceutical, or

(b) an empty vial or other accessory item in a kit; (constituants)

“kit” means a package

(a) that contains one or more separately packaged units of a drug, other than a radionuclide, and

(b) that may contain empty vials or other accessory items, for use in the preparation of radiopharmaceuticals. (trousse)

SOR/79-236, s. 4.

C.03.206. Sections C.01.005 and C.04.019 do not apply to a component or kit.

SOR/79-236, s. 4.

C.03.207. Every component shall be labelled to show

(a) adequate identification of the component and an adequate description of its function;

(b) where applicable, a quantitative list of its ingredients or a reference to the label of the kit that shows such information;

(c) the name of the distributor referred to in paragraph C.01A.003(b);

(d) the lot number;

(e) a statement of any special storage requirements with respect to temperature and light;

(f) the date after which the component is not recommended for use, the name of the month being written in full or designated by letter abbreviation; and

(g) adequate directions for use or a reference to the accompanying package insert that shows such directions.

SOR/79-236, s. 4; SOR/97-12, s. 58.

C.03.208. Every kit shall be labelled to show

(a) its proper name;

(b) its brand name, if any;

(c) a list of its contents;

(d) the name and address of the distributor referred to in paragraph C.01A.003(b);

(e) the establishment licence number of the distributor preceded by the words “Establishment Licence Number”, “Numéro de licence d’établissement” or an abbreviation thereof;

(f) the lot number;

(g) a statement of any special storage requirements with respect to temperature and light;

(h) the date after which the kit is not recommended for use, the name of the month being written in full or designated by letter abbreviation;

(i) where the label of a component makes reference to the label of the kit that shows information as to the ingredients of the component, a quantitative list of the ingredients of that component;

(j) a statement of the sterility and apyrogenicity of the components;

(k) adequate directions for preparing the radiopharmaceutical or a reference to the accompanying package insert that shows such directions;

(l) a statement of the duration of the useful life of the prepared radiopharmaceutical;

(m) a statement of the storage requirements for the prepared radiopharmaceutical;

(n) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use, or a reference to the accompanying package insert that shows such information; and

(o) a statement of the route of administration of the prepared radiopharmaceutical.

(p) [Repealed, SOR/2001-203, s. 3]

SOR/79-236, s. 4; SOR/93-202, s. 18; SOR/97-12, ss. 58, 62; SOR/2001-203, s. 3.

C.03.209. A package insert shall be included in every kit and shall show

(a) the proper name and the brand name, if any, of the kit and a description of its use;

(b) a list of the contents of the kit;

(c) the name and address of the distributor referred to in paragraph C.01A.003(b) of the kit;

(d) identification of the radionuclides that can be used to prepare the radiopharmaceutical;

(e) directions for preparing the radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;

(f) a statement of the duration of the useful life of the prepared radiopharmaceutical;

(g) a description of the biological actions of the prepared radiopharmaceutical;

(h) indications and contraindications in respect of the prepared radiopharmaceutical;

(i) warnings and precautions in respect of the components and the prepared radiopharmaceutical;

(j) the adverse reactions, if any, associated with the prepared radiopharmaceutical;

(k) where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical or a statement that such information is available on request;

(l) the radiation dosimetry in respect of the prepared radiopharmaceutical;

(m) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use;

(n) a statement of the route of administration of the prepared radiopharmaceutical; and

(o) a recommendation that the radiochemical purity and radioactivity content of the prepared radiopharmaceutical be checked prior to administration.

SOR/79-236, s. 4; SOR/93-202, s. 19; SOR/97-12, s. 58.