Food and Drug Regulations (C.R.C., c. 870)

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

• (a) dispensed by a pharmacist pursuant to a prescription; or

• (b) sold for veterinary use only.

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.”

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

• (a) are sold for veterinary use only;

• (b) are dispensed by a pharmacist pursuant to a prescription; or

• (c) contain 100 milligrams or less of elemental potassium per tablet.

C.01.401. Except as provided in these Regulations, an antibiotic for other than parenteral use shall, in addition to meeting the requirements of section C.01.004, carry on both the inner label and outer label the potency of the drug, expressed in terms of International Units where established or, if no International Unit has been established, in terms of units, milligrams, micrograms or fractions of a gram,

• (a) per gram in the case of solids or viscous liquids;

• (b) per millilitre in the case of other liquids; and

• (c) per individual dosage or dispensing form in the case of antibiotic preparations put up in individual dosage or dispensing form.

C.01.402. [Repealed, SOR/92-654, s. 4]

C.01.410. to C.01.412. [Repealed, SOR/80-544, s. 8]

C.01.420. to C.01.422. [Repealed, SOR/80-544, s. 8]

C.01.430. to C.01.432. [Repealed, SOR/80-544, s. 8]