Part C - Food & Drugs Act (Drugs)

Question 1

Sec. 12 of the FDA outlines that drugs in Schedule C or D require suitable manufacturing processes & conditions… What are these drugs?

Answer 1

C: Includes things such as Radiopharmaceuticals

D: Drugs with Biological Components

Question 2

Sec. 21 outlines the extended powers of the Minister… What can they do without authorization from the manufacturer of a drug?

Answer 2

-Can order manufacture to modify labelling or recall products if they pose a public health risk

-Can receive & disclose confidential information about a product if there’s reasonable grounds that it provides a public health risk

Question 3

What is the overarching takeaway regarding Admin & Enforcement of Pt. II of the FDA?

Answer 3

-Minister can designate Inspectors who can then inspect manufacturing premises & seize property.

-Manufacturers cannot obstruct / hinder / make false or misleading statements to Inspectors.

Question 4

Sec. 29.1 (1) allows the Minister to do what?

Answer 4

-Ability to Add or Delete drugs from Rx Drug List of the FDA.

Question 5

Inner & Outer Labels of Drugs in Part C must contain what information?

Answer 5

-Name & Address of Manufacturer

-Lot # of drug

-Directions for use

-List of medicinal ingredients by proper name (or by common name)

-Expiration date

Question 6

Outer Labels of a drug must contain what information?

Answer 6

-Net amt. of drug

-(Parenteral Use Drugs) List of preservatives by either proper or common name

-(Drugs w Mercury or Salts or Mercury Derivatives) List of mercurial preservatives present by proper name or common name

Question 7

Inner Labels of a drug must contain what information?

Answer 7

-Drug Name
-Potency
-Net Contents
-Route of Admin
-Lot #
-Expiry

Question 8

All manufactured drugs must have DINs on the label… With the exception of what?

Answer 8

Unless Pharmacist compounded under a prescription or sold under a prescription containing:

-Drug Name
-Drug Potency
-Name of Manufacturer

Question 9

No Pharmacists or Practitioners shall sell Class A Opioids without what?

Answer 9

-Warning Sticker

-Pt. Info Handout that accompanies drug receiving

Question 10

Within what length of time must serious or unexpected adverse drug reactions be reported to Manufacturers or HC?

Answer 10

15d

Question 11

What drugs require cautionary statements because of their risk to impart serious harm to children?

Answer 11

-ASA
-Salicylic Acid
-Acetaminophen
-Elemental Iron
-Fluoride Iron
-Nicotine in Vape Products

Question 12

Drugs outlined in C.01.029 (1) cannot be sold for pediatric usage unless they are packaged in what way?

Answer 12

Child Resistant Packaging

Question 13

Manufacturers are not allowed to sell drugs for human consumption that contain what?

Answer 13

-Mercury (or Mercury Salts or Mercury Derivatives)

-Chloroform

-Arsenic

Question 14

Drugs for human consumption are considered adulterated if they contain what?

Answer 14

Strychnine (or its salt forms)

Question 15

Verbals must have accompanying written records that contain what information?

Answer 15

-Date Rx was received

-Name & Address of person to whom Rx was issued

-Proper, common, or brand name of drug & qty.

-Person’s name & Practitioner name

-Directions for use

-Number of refills

Question 16

Who under Part C of the FDA is authorized to import Rx drugs?

Answer 16

-Practitioner
-Drug Manufacturer
-Wholesale Druggist
-Pharmacist
-Residents of Foreign Countries who are visiting Canada

Question 17

If drugs are sold for vet use, what things must be required of that prescription?

Answer 17

-In a form not suitable for human consumption

or

-“For Vet Use Only” statement on inner & outer labels

Question 18

To meet Good Manufacturing Processes outlined in the FDA, what must manufacturer premises & equipment allow for?

Answer 18

-Proper cleaning & sanitation

-Prevention of contamination

-Function optimally

-Personnel training

-Written & implemented sanitation programs

Question 19

S 96