PART CDrugs (continued)
DIVISION 1 (continued)
Limits of Variability (continued)
C.01.063 [Repealed, SOR/96-399, s. 2]
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.
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.
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.
(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.
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.
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.
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.
Mercuric Chloride Tablets
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
(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
- SOR/2001-181, s. 2.
C.01.081 [Repealed, SOR/80-544, s. 4]
C.01.085 [Repealed, SOR/80-544, s. 5]
(2) [Repealed, SOR/78-800, s. 1]
(3) [Repealed, SOR/78-422, s. 3]
C.01.121 and C.01.122 [Repealed, SOR/80-544, s. 6]
Aminopyrine and Dipyrone
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).
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.
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
Coated Potassium Salts
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).
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.
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
- Date modified: