Federal FDA

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20 Terms

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Food and Drugs Act (FDA)

A Canadian law that regulates the importation, manufacturing, and distribution of drugs.

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Schedule A

Lists disease states for which treatments cannot be promoted to the public without complying with specific advertising requirements.

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Schedule B

Contains official or international standards that drugs and substances sold in Canada must meet.

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Schedule C

Refers to radiopharmaceuticals.

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Schedule D

Includes allergenic substances, blood derivatives, and immunizing agents.

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Controlled Drugs

Drugs that are regulated due to their potential for abuse, covered under Schedule G.

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Prescription Drug List (PDL)

A list of drugs that excludes those found in the Controlled Drug and Substances Act.

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Natural Health Products Regulations

Regulations that pertain to natural health products in Canada.

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Medical Devices Regulations

Regulations covering the approval and safety standards for medical devices in Canada.

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Good Manufacturing Practices (GMP)

A system for ensuring that products are consistently produced and controlled according to quality standards.

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Child Resistant Package

A package that meets specific safety standards to prevent children from accessing harmful substances.

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Drug Identification Number (DIN)

A unique number assigned by Health Canada that indicates a drug has been approved for sale.

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Compounding

The process of preparing personalized medications for patients based on specific prescriptions.

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Health Canada

The Canadian federal department responsible for helping Canadians maintain and improve their health.

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Market Authorization

The approval given by Health Canada allowing the sale of a drug after demonstrating its safety and efficacy.

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Drug Establishment Licences (DEL)

Licenses issued by Health Canada to regulate the manufacturing and distribution of drugs.

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Practitioner

A person legally entitled to treat patients with prescription drugs in their province.

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Lot Numbers

Unique identifiers assigned to batches of products to track their production and distribution.

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Expiration Date

The date until which a drug is expected to remain effective and safe.

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Pharmaceutical Company

A company that engages in the research, development, manufacturing, and distribution of medications.