Lecture 6: Intro to Jurisprudence Flashcards
_______, ________, and ________ are part of federal legislation
Controlled Drug and Substances Act (CDSA)
Food and Drug Act (FDA)
Personal Information and Electronic Documents Act
which part of federal leg pertains to drugs and PDL?
Food and Drug Act (FDA) (also have NHP regulations)
_______, ________, ________, and ________ are part of provincial legislation
Health Professions Act
Pharmacy and Drug Act
Personal Information Protection Act
Health Information Act
what is the diff b/w Act, Regulations, and Bylaws for organizations?
Act contains policy statements and schedules
Regulations contain procedure statements and schedules
bylaws contain administration, ethics, and SOPs
Therapeutic Products Directorate is under?
what are 2 subsets of the Therapeutic Products Directorate?
Health Canada -> Health Pdts and Food Branch
Medical Devices Bureau, Special Access Programmes
What power does Health Minister have?
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
Food and Drug Act
How many parts and schedules?
2 Parts and 4 Schedules Part I (foods, drugs, cosmetics, devices) Part II (administration and enforcement - power for Health Minister)
Food and Drug Act
How many branches of FDA?
Includes Food and Drug Regulations, Natural Health Products Regulations, Medical Devices Regulations
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?
Advertisement
what is any person so designated for the purpose of enforcement of the Act?
Inspector
what is any legend, word or mark attached, included or belonging to a drug?
Label
name 3 functions of drugs
“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
name 4 uses of devices
would a contraceptive be a device?
“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;
Food and Drug Act PART I
What 8 sections are relevant to pharmacy?
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
Food and Drug Act PART I
when is advertising prohibited?
when is sale prohibited?
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
Food and Drug Act PART I
What is a sample? who can distribute them?
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
Food and Drug Act PART I
what drugs cannot be sampled?
what must be recorded when a sample is distributed?
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…
- Name and address and description of person
- Brand Name, quantity, and form of drug
- Date of distribution
- Keep minimum of 2 years from last fill
- assessment is necessary, as well as documenting - cannot give investigational drug
Food and Drug Act PART I
What are the requirements for pts for samples normally requiring a presc and not requiring a presc?
- 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
Food and Drug Act PART II
how many sections are relevant to pharmacy?
which 2?
1. Addresses Administration • Inspector • Regulations 2. Addresses Enforcement • Contravention • Fines • Prison
Schedules to FDA (4)
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
