Lecture 6: Intro to Jurisprudence

Question 1

_______, ________, and ________ are part of federal legislation

Answer 1

Controlled Drug and Substances Act (CDSA)
Food and Drug Act (FDA)
Personal Information and Electronic Documents Act

Question 2

which part of federal leg pertains to drugs and PDL?

Answer 2

Food and Drug Act (FDA) (also have NHP regulations)

Question 3

_______, ________, ________, and ________ are part of provincial legislation

Answer 3

Health Professions Act
Pharmacy and Drug Act
Personal Information Protection Act
Health Information Act

Question 4

what is the diff b/w Act, Regulations, and Bylaws for organizations?

Answer 4

Act contains policy statements and schedules
Regulations contain procedure statements and schedules
bylaws contain administration, ethics, and SOPs

Question 5

Therapeutic Products Directorate is under?

what are 2 subsets of the Therapeutic Products Directorate?

Answer 5

Health Canada -> Health Pdts and Food Branch

Medical Devices Bureau, Special Access Programmes

Question 6

What power does Health Minister have?

Answer 6

Food and Drugs Act gives power to Health Minister
(Patty Hajdu)
- Federal Health Minister can regulate, inspect, seize, impose penalties
- safety , quality of drugs, foods, cosmetics and devices can be checked

Question 7

Food and Drug Act

How many parts and schedules?

Answer 7

2 Parts and 4 Schedules
Part I (foods, drugs, cosmetics, devices)
Part II (administration and enforcement - power for Health Minister)

Question 8

Food and Drug Act

How many branches of FDA?

Answer 8

Includes Food and Drug Regulations, Natural Health Products Regulations, Medical Devices Regulations

Question 9

what is any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic, or device?

Answer 9

Advertisement

Question 10

what is any person so designated for the purpose of enforcement of the Act?

Answer 10

Inspector

Question 11

what is any legend, word or mark attached, included or belonging to a drug?

Answer 11

Label

Question 12

name 3 functions of drugs

Answer 12

“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

Question 13

name 4 uses of devices

would a contraceptive be a device?

Answer 13

“device” means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, 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 a body function or the body structure of human beings or animals,
(c) the diagnosis of pregnancy in human beings or animals, or
(d) the care of human beings or animals during pregnancy and at and after
birth of the offspring, including care of the offspring,
• and includes a contraceptive device but does not include a drug;

Question 14

Food and Drug Act PART I

What 8 sections are relevant to pharmacy?

Answer 14

Section #1. Prohibited Advertising
Section #2. Prohibited Sale
Section #3. 9 (1) Deception
Section #4. 10 (1) Standard Prescribed
Section #5. 11 Unsanitary Manufacture
Section #6. 12 Safe Manufacture Schedule C and D
Section #7. 14 Samples (see next slide)
Section #8. 15 Outlines Schedule F sale requirements (Schedule F is now the Prescription drug List (PDL))

• PT I addresses Public Safety

Question 15

Food and Drug Act PART I

when is advertising prohibited?
when is sale prohibited?

Answer 15

No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.

sell
(a) was manufactured, prepared, preserved, packaged or stored under
unsanitary conditions; or
• (b) is adulterated

Question 16

Food and Drug Act PART I

What is a sample? who can distribute them?

Answer 16

Sample - a trial package of medication provided to a pharmacist free of cost

No person shall distribute or cause to be distributed any drug as a sample

Exception
Subsection (1) doesn’t apply to distribution under prescribed conditions, of samples of drugs to physicians, dentists, veterinary surgeons or pharmacists

Question 17

Food and Drug Act PART I

what drugs cannot be sampled?

what must be recorded when a sample is distributed?

Answer 17

Mfr distributing samples
• Signed order (brand name, common name, quantity)
• May specify repeats (to be filled within 6 mos)

Not Narcotic or Controlled or New Drug (no DIN)

The person distributing the sample must record…

1. Name and address and description of person
2. Brand Name, quantity, and form of drug
3. Date of distribution
4. Keep minimum of 2 years from last fill
   - assessment is necessary, as well as documenting - cannot give investigational drug

Question 18

Food and Drug Act PART I

What are the requirements for pts for samples normally requiring a presc and not requiring a presc?

Answer 18

• must inform pt if sample is given
  Drugs requiring a prescription:
  • May dispense pursuant to a prescription if:
  • Labeled appropriately. Apply prescription requirements.
  • Charge fee but not cost
  • Inform the patient a sample is used

Drugs not requiring a prescription:
• Distribution must be done in compliance with conditions for sale
regarding the drug scheduling system (Alberta rules) and the F&D Regulations.

• counselling/dispensing fee may be applied but no markup for the drug

Question 19

Food and Drug Act PART II

how many sections are relevant to pharmacy?
which 2?

Answer 19

1. Addresses Administration
• Inspector
• Regulations
2. Addresses Enforcement
• Contravention
• Fines
• Prison

Question 20

Schedules to FDA (4)

Answer 20

Schedule A: disease states or conditions for which treatments may not be promoted to the public

• Asthma, cancer, depression
• Must comply with specific requirements if advertising any product for these conditions
• Advertising to public restricted

Schedule B: publications describing official/international standards
- so public can be satisfied with pdts as standard

Schedule C: Radiopharmaceuticals

Schedule D: Allergenic Substances, Blood Derivatives, Immunizing Agents
- Regulated substances must meet specific requirements for C and D