Prescription Drugs

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 61-68

FOUR

Prescription Drugs

A. INTRODUCTION

Certain drugs are classied as prescription drugs because the supervision of

a practitioner is necessary to address the risks associated with them. “Practi-

tioner” is dened 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-

tication number (DIN), this chapter explains the criteria for determining

if a drug is a “prescription drug” and the consequences of that classication.

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.”