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</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</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)</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</p> Signup and view all the answers

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

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

    More Like This

    Use Quizgecko on...
    Browser
    Browser