Pharmaceutical Regulations: FDA, CDSA, and Health Products
18 Questions
1 Views

Choose a study mode

Play Quiz
Study Flashcards
Spaced Repetition
Chat to Lesson

Podcast

Play an AI-generated podcast conversation about this lesson

Questions and Answers

What is the most serious type of recall classified by the Health Products and Foods Branch?

  • Type II
  • Type I (correct)
  • Type IV
  • Type III

Where are drugs listed under the same schedules across Canada?

  • Health Canada website
  • FDA website
  • NAPRA website (correct)
  • Med Effect Canada website

What is the purpose of Med Effect Canada?

  • To provide information on drug schedules
  • To regulate drug sales across Canada
  • To provide licenses to establishments
  • To provide information on adverse reactions and new safety information (correct)

What type of drugs require professional intervention at the point of sale?

<p>Schedule II drugs (D)</p> Signup and view all the answers

What is the role of Health Professionals in reporting adverse reactions?

<p>To report directly to Health Canada (C)</p> Signup and view all the answers

Which federal act is related to the regulation of controlled drugs and substances?

<p>The Controlled Drugs and Substances Act (CDSA) (B)</p> Signup and view all the answers

What is the purpose of a child resistant package according to the discussed regulations?

<p>To prevent children from accessing medication (D)</p> Signup and view all the answers

What is the required retention period for prescription records in Ontario?

<p>10 years (A)</p> Signup and view all the answers

What is the reason a patient may be dispensed with a snap-cap instead of a child resistant package?

<p>The patient has difficulty using a child resistant cap (A)</p> Signup and view all the answers

What is the reason a pharmacist may refuse to fill a prescription?

<p>Based on their professional judgment (D)</p> Signup and view all the answers

What is the minimum retention period for records of sale transactions required by the Canada Revenue Agency?

<p>7 years (B)</p> Signup and view all the answers

What is the purpose of the Part D of the regulation?

<p>Dealing with vitamins, minerals, and amino acids (C)</p> Signup and view all the answers

Which of the following schedules under the Act lists diseases or disorders for which treatment may not be advertised to the public?

<p>SCH A (B)</p> Signup and view all the answers

What is the main criterion for a drug to be included in the Prescription Drug List (PDL)?

<p>The drug requires supervision of a practitioner for diagnosis, treatment, or prevention of a condition (C)</p> Signup and view all the answers

Which part of the Food and Drug Regulations deals with the manufacturing and labeling of non-controlled drugs?

<p>Part C (C)</p> Signup and view all the answers

What is the main purpose of the Food and Drug Regulations?

<p>To provide rules for pharmacy practice (D)</p> Signup and view all the answers

Which of the following is NOT a criterion for a drug to be included in the Prescription Drug List (PDL)?

<p>The drug has a low level of uncertainty with its effects (B)</p> Signup and view all the answers

Which of the following regulations is used for pharmacy practice, in addition to the Food and Drug Regulations?

<p>Natural Health Products Regulations (B)</p> Signup and view all the answers

More Like This

Use Quizgecko on...
Browser
Browser