Drug Standards

Drug Quality

  • What is a drug? Section 2 of the Food and Drug Act defines a drug as follows:
    • "drug" includes any substance or mixture of substances manufactured, sold or represented for use in:
    • (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
    • (b) restoring, correcting or modifying organic functions in human beings or animals, or
    • (c) disinfection in premises in which food is manufactured, prepared or kept;
  • Food and Drug Regulations set the standards of composition, strength, potency, purity, quality or other property of drug (and food, as well) to which they refer.
  • New drugs must be significantly tested through clinical trials, and approved by the Minister of Health, before they may be sold to the public in Canada.