Prescription Drugs
Author | T. Nessim Abu-Zahra/Simon Carvalho/David Edwards |
Pages | 61-68 |
FOUR
Prescription Drugs
A. INTRODUCTION
Certain drugs are classied as prescription drugs because the supervision of
a practitioner is necessary to address the risks associated with them. “Practi-
tioner” is dened in C..() of the Food and Drug Regulations (FDRs) as
a person who () is entitled under the laws of a province to treat patients with
a prescription drug, and ()is practising their profession in that province.
Consumers can only obtain these drugs pursuant to a prescription given
by a practitioner, such as a physician or, in some cases, another health care
professional such as a nurse practitioner. Prescription drugs are generally
kept behind the counter in a pharmacy and are dispensed by a pharmacist.
Any drug that is subject to the FDRs may be a prescription drug. In
other words, both “new drugs” that are subject to Division and drugs that
are not “new drugs” may be prescription drugs. Whereas Chapter discussed
the rules regarding obtaining a notice of compliance (NOC) and drug iden-
tication number (DIN), this chapter explains the criteria for determining
if a drug is a “prescription drug” and the consequences of that classication.
is chapter will rst explain the process for determining whether a
drug is a “prescription drug” and then explain the rules regarding the sale,
advertising, and importation of prescription drugs.
A.. of the Food and Drug Regulations, CRC, c ,provides as follows: “prescrip-
tion drug means a drug that is set out in the Prescription Drug List, as amended from
time to time, or a drug that is part of a class of drugs that is set out in it.”
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