Review of the FDA and FDR

Legislative Structure

100

This part of the Food and Drugs Act lists information about controlled drugs 

Part G

200

This schedule in the Food and Drugs Act lists information about vaccines and hormones. 

Schedule D

300

The FDA is the overarching legislation for the Food and Drug Regulations and what other piece of legislation?

Natural Health Product Regulations

400

This part of the Food and Drug Regulations contains definitions and other general information (answer should contain both Part and Division)

What is Part C, Division 1: General

500

Where would one find information about pharmacy license requirements?

Food and Drug Regulations

Part C Drugs

Division: 1A Establishment Licenses

Definitions

100

This refers to drugs that have been assigned a DIN but the manufacturer permanently stops the sale of a drug

Discontinue

200

This refers to drug administered by injection or other means through or into the skin or mucous membrane. 

Parenteral Use

300

This refers to an unintended response to a drug when used at normal doses 

Adverse Drug Reaction 

400

This refers to the part of the stock bottle that is immediate contact with a drug

Immediate Container

500

This means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order

Prescription

Drug Label Requirements

100

C.S.D. stands for what? 

Canadian Standard Drug

200

The letters in this symbol indicate that the drug is a prescription drug. 

Pr

300

The outer label must include any preservatives in the product if the drug is for what use?

Parenteral

400

The requirement for "USP", "BP" or "NF" to be listed in the drug name is found in what section of the Food and Drugs Act?

Food and Drug Act Schedule B (Drug Standards)

500

This is NOT required on an inner label so long as it is on the outer label.

DIN

Acetaminophen and ASA

100

This is the strength of an acetaminophen tablet for children.

80mg

200

Children under 18 years of age are at risk of developing this adverse reaction if they take ASA (acetylsalicylic acid)

Reye's Syndrome

300

This is the maximum number of tablets in a package of junior strength acetaminophen.

20

400

This is the total daily dosage maximum of acetaminophen

4g

500

This the maximum amount of drug allowed in a container of ASA that is marketed towards children

1.92g

Potpourri

100

Drugs advertised for human use may only contain brand name, proper name, price and what?

Quantity

200

A transferred prescription must be kept for how long by the pharmacy that received the transfer?

2 years 

300

Prescription drugs may be imported into Canada by practitioners, drug manufacturers, wholesalers, pharmacists, and these 

Residents of a foreign country while visiting Canada

400

The requirement for a manufacturer to have a Quality Control department is found in which piece of legislation?

FDR

Part C: Drugs

Division 2: Good Manufacturing Practices

500

This is the maximum time that a patent can protect a specific product from being duplicated by another manufacturer. 

20 Years