PART CDrugs (continued)
DIVISION 4 (continued)
Schedule D Drugs (continued)
C.04.001.1 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. 32
C.04.002 This Division does not apply to a drug in oral dosage form that contains micro-organisms if the drug is recommended solely for restoring, normalizing or stabilizing the intestinal flora.
- SOR/97-12, s. 33
C.04.003 The date of issue of a drug shall be the date on which the finished product is removed from cold storage but in any case shall be, not later than
(a) six months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 10°C;
(b) 12 months after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 5°C; or
(c) two years after the date of manufacture for a drug that has been kept constantly at a temperature not exceeding 0°C.
C.04.004 to C.04.006 [Repealed, SOR/97-12, s. 34]
C.04.007 [Repealed, SOR/97-12, s. 67]
C.04.008 to C.04.012 [Repealed, SOR/97-12, s. 36]
C.04.013 Every fabricator and packager/labeller shall safely segregate all work with spore-bearing, pathogenic micro-organisms and other infectious agents known to require special precautions in manipulation and shall take such care of equipment and arrangements for supervision that the possibility of contamination of other drugs is avoided.
- SOR/97-12, s. 63
C.04.014 No person shall conduct laboratory procedures of a diagnostic nature in their premises unless those procedures are entirely segregated from the fabrication, packaging/labelling and testing of drugs.
- SOR/97-12, s. 37
C.04.015 On written request from the Minister, 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 of the drug before it is sold, and no person shall sell any lot of that drug if the protocol or sample fails to meet the requirements of these Regulations.
- SOR/97-12, s. 37
- SOR/2018-69, s. 27
C.04.016 All animals from which drugs are prepared and preserved shall be
(a) under the direct supervision of competent medical or veterinary personnel;
(b) kept in quarantine by the fabricator for at least seven days before use; and
(c) healthy and free from infectious disease.
- SOR/97-12, s. 38
C.04.017 A fabricator shall keep necropsy records of all animals that die or are killed after having been used in the production of a drug.
- SOR/97-12, s. 61
C.04.018 A fabricator shall immediately segregate, and report the fact to the Minister, any animal with actual or suspected vesicular stomatitis, foot and mouth disease, encephalomyelitis, infectious anaemia, glanders, anthrax, tetanus or any other serious infectious disease.
- SOR/97-12, s. 61
C.04.019 The provisions of section C.01.004 do not apply to a drug as defined in this Division but every package of such drug 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 in type not less than one-half the size of that of the brand name,
(ii) the name of the distributor referred to in paragraph C.01A.003(b),
(iii) the potency of the drug, where applicable,
(iv) the recommended dose of the drug,
(v) the lot number,
(vi) the expiration date except upon the inner label of a single-dose container, and
(vii) adequate direction for use; and
(b) on the outer label
(i) the address of the distributor referred to in paragraph C.01A.003(b),
(ii) [Repealed, SOR/2013-179, s. 3]
(iii) the proper name, or the common name if there is no proper name, and the amount, of any preservative in the drug,
(iv) a statement that the drug shall be stored at a temperature of not less than 2°C and not more than 10°C, unless the Minister has received evidence demonstrating that such a statement is not required,
(v) a statement of the net contents in terms of weight, measure, or number, and
(vi) in the case of a new drug for extraordinary use in respect of which a notice of compliance has been issued under section C.08.004.01, the following statement, displayed in capital letters and in a legible manner:
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR [naming purpose] BASED ON LIMITED CLINICAL TESTING IN HUMANS.
SANTÉ CANADA A AUTORISÉ LA VENTE DE CETTE DROGUE NOUVELLE POUR USAGE EXCEPTIONNEL AUX FINS DE [indication de la fin] EN SE FONDANT SUR DES ESSAIS CLINIQUES RESTREINTS CHEZ L’ÊTRE HUMAIN.”.
- SOR/78-424, s. 7
- SOR/93-202, s. 21
- SOR/97-12, ss. 39, 54, 58
- SOR/2011-88, s. 6
- SOR/2013-179, s. 3
C.04.020 Except in the case of the following drugs, every package of a drug that is a prescription drug 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:
(a) a drug sold to a person who holds an establishment licence; and
(b) a drug sold under a prescription.
- SOR/80-543, s. 10
- SOR/97-12, s. 40
- SOR/2001-181, s. 4
- SOR/2013-122, s. 17
Bacterial Vaccines, Products Analogous to Bacterial Vaccines
C.04.050 Except as provided in this Division, a bacterial vaccine shall be a sterile suspension of killed cultures of bacteria, with or without the addition of other medication, and shall not include an autogenous vaccine.
C.04.051 No person shall sell a bacterial vaccine unless the culture that has been used in its preparation has been tested by an acceptable method for identity and purity and when so tested it shall be true to name and a pure strain, and a record of the culture shall be maintained which shall include a statement of its origin, properties and characteristics.
C.04.052 No fabricator shall use a substrate (culture medium), in the production of a bacterial vaccine, that contains any horse meat or horse serum.
- SOR/97-12, s. 61
C.04.053 A fabricator of a bacterial vaccine prepared from a bacterium that does not grow readily in ordinary culture media shall test its sterility in media which are specially favourable to the growth of such bacterium, and it shall be sterile.
- SOR/97-12, s. 61
C.04.054 Except as provided in sections C.04.083, C.04.084 and C.04.090, both the inner and outer labels of every multiple-dose container and the outer label of every single-dose container of a bacterial vaccine shall carry a statement of
(a) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre,
(b) the number of bacteria per millilitre, or the weight of dried substance of bacteria per millilitre, of each species or immunogenic type for a vaccine that contains a number of different species or immunogenic types of bacteria,
(c) the exact nature and amount of any substance, other than a simple diluent, combined with such vaccine, and
(d) the recommended dose,
and the inner label of a single-dose container shall carry a statement that it contains only one dose.
C.04.055 The expiration date of a bacterial vaccine shall be not later than 18 months after the date of manufacture or the date of issue.
C.04.060 Cultures of Salmonella typhosa used in the preparation of typhoid vaccine shall be smooth, motile, and in the Vi form, with the following antigenic structure IX,XII,Vi; d.-.
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