Pharmaceutical Regulations: FDA, CDSA, and Health Products

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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?

Schedule II drugs Signup and view all the answers

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

To report directly to Health Canada Signup and view all the answers

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

The Controlled Drugs and Substances Act (CDSA) Signup and view all the answers

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

To prevent children from accessing medication Signup and view all the answers

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

10 years 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?

The patient has difficulty using a child resistant cap Signup and view all the answers

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

Based on their professional judgment Signup and view all the answers

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

7 years Signup and view all the answers

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

Dealing with vitamins, minerals, and amino acids 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?

SCH A Signup and view all the answers

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

The drug requires supervision of a practitioner for diagnosis, treatment, or prevention of a condition Signup and view all the answers

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

Part C Signup and view all the answers

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

To provide rules for pharmacy practice 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)?

The drug has a low level of uncertainty with its effects Signup and view all the answers

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

Natural Health Products Regulations Signup and view all the answers