JP3

Question 1

what does FDA give minister of Helath the right to do

Answer 1

regulate, inspect, seize and impose penalties on all activities dealing with drugs, foods, cosmetics and medical devices.

Question 2

what are the schedules of the FDA

Answer 2

A: Disease states or conditions for which treatments may not be promoted to the public. Any condition found listed in this schedule such as asthma, cancer or depression, must comply with specific requirements if advertising any product promoted as a treatment or cure for these listed conditions. Advertising to the public, i.e. consumers, is restricted.

B: Publications describing official or international standards. Any substance or drug to be sold in Canada must meet the criteria outlined in these standards. This is to ensure that the public can be satisfied that the product is what it claims to be and that they are not receiving a substandard or counterfeit product.

C: Radiopharmaceuticals*

D: Allergenic substances, blood derivatives and immunizing agents as well as others.*

Question 3

What are the parts of the food and drug regulation

Answer 3

1. Part A
   
   • Covers administration
2. Part B
   
   • Deals with food production and safety.
   • Also oversees food and safety inspection.
3. Part C
   
   • Deals with drugs and defines the rules for dispensing. Everything from raw materials to final consumer products
   • differnt symbols (Pr, N, C, TC)
4. Part D
   
   • Vitamines, minerals and amino acids
5. Part E
   
   • Cyclamate and sacchrin sweeteners
6. Part G
   
   • Controlled drugs
7. Part J
   
   • restricted drugs

Question 4

regualtions of manufacturing

Answer 4

• by FDA
• must follow GMP
• approved manufactued drugs must have DIN
• establishment must have a DEL (drug establihshment license)
• all establishments undergo regualr inspections
• failure to maintain GMP can result in fines, suspection or license removal
• licenses may have terms, limits or conditions

Question 5

what must a DIN identifiy

Answer 5

Name

Manufacturer

Active ingredients

Strength

Dosage form

Question 6

what is a DEL required for?

Answer 6

Fabricate or manufacture drugs

o Package and/or label products

o Test drugs

o Distribute various classes of drugs

o Import or wholesale drugs

Question 7

conditions for compounding drugs

Answer 7

• Are prepared pursuant to a prescription within an established pharmacist-patient relationship.
• Require consultation between the pharmacist and the patient (or patient’s agent) in which the pharmacist uses their knowledge and expertise.
• Provides a customized therapeutic solution to improve patient care.
• Do not circumvent a regulatory process or patent laws.

*controlled act but other health professionals have access to it

Question 8

types of Recall

Answer 8

1. Type I:
   
   • The most serious recall
   • There is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.
2. Type II:
   
   • Use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
3. Type III:
   
   • Use of, or exposure to, a product is not likely to cause any adverse health consequences.

Question 9

If a manufacturer gets report of adver raction what must they do

Answer 9

report to health canada within 15 days

Question 10

what is Health Canadas post market surveillance program

Answer 10

MedEffect Canada

• consumers, patients and health professionals can report adver rxns or side efects
• they collect and asses reports of both prescription and non prescription medications, natural health products and vaccines

*if multiple reports received for specific drug, they may order a review of product

• post warnings, advisories and any recalls that are in effect

Question 11

what is the PDL

Answer 11

• in FDA
• miniter of health has authority to edit
• has two sections: human and veterinary use

*all drugs on PDL will fall into Schedule 1 of NAPRA and have a Pr symbol

*does not included controled substances

Question 12

criteria to determine if drug belongs on PDL

Answer 12

• A drug that requires the supervision of a practitioner for the diagnosis, treatment or prevention of a disease or disorder for which the drug is recommended and for monitoring the drug’s use.
• Consideration to the level of uncertainty with the drug’s use or its effects.
• Potential harm that a drug could cause that would require supervision by a practitioner.

Question 13

ex of scheudle 1 drug that is not on PDL

Answer 13

Bactroban (mupirocin)

*needs a preciption in Ontario but bottle will not have a Pr

Question 14

Drugs schedules/lists requiring a prescription

Answer 14

Federal/Health Canada: Drugs in PDL, narcotics (N), Controlled drugs (G), Benzos and other targeted substances (C/T)

• NAPRA; only schedule I