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Questions and Answers
What is the criteria for a drug to be deemed adulterated under paragraph (b)?
What is the criteria for a drug to be deemed adulterated under paragraph (b)?
- If its label does not explicitly state its difference in strength, safety, efficacy, quality, or purity from the standards set forth in an official compendium.
- If its strength differs from the standards set forth in an official compendium without explicit labeling.
- If its difference in strength, safety, efficacy, quality, or purity from the standards set forth in an official compendium is not approved for registration.
- If its safety, efficacy, quality, or purity falls below the standards set forth in an official compendium. (correct)
What is the exception to the rule that a drug's strength, safety, efficacy, quality, or purity must meet the standards set forth in an official compendium?
What is the exception to the rule that a drug's strength, safety, efficacy, quality, or purity must meet the standards set forth in an official compendium?
- If the drug is not represented as a drug recognized in an official compendium.
- If the Department promulgates regulations prescribing appropriate tests or methods of safety, efficacy, quality, or purity.
- If the drug's label explicitly states its difference in strength, safety, efficacy, quality, or purity from the standards set forth in an official compendium. (correct)
- If the drug is approved for registration despite not meeting the standards set forth in an official compendium.
What is the consequence of a drug's strength, safety, efficacy, quality, or purity falling below the standards set forth in an official compendium?
What is the consequence of a drug's strength, safety, efficacy, quality, or purity falling below the standards set forth in an official compendium?
- The drug is prohibited from being sold.
- The drug is deemed misbranded.
- The drug is subject to further testing and evaluation.
- The drug is deemed adulterated under paragraph (b). (correct)
What is the purpose of the Department's regulations prescribing appropriate tests or methods of safety, efficacy, quality, or purity?
What is the purpose of the Department's regulations prescribing appropriate tests or methods of safety, efficacy, quality, or purity?
What is the criteria for a drug to be deemed adulterated under paragraph (c)?
What is the criteria for a drug to be deemed adulterated under paragraph (c)?
What is the consequence of a drug or device having a substance mixed or packed with it, or having a substance substituted wholly or in part, so as to reduce its safety, efficacy, quality, strength, or purity?
What is the consequence of a drug or device having a substance mixed or packed with it, or having a substance substituted wholly or in part, so as to reduce its safety, efficacy, quality, strength, or purity?
What is the relevance of an official compendium in determining a drug's adulteration?
What is the relevance of an official compendium in determining a drug's adulteration?
What is the role of the Department in ensuring drug safety, efficacy, quality, or purity?
What is the role of the Department in ensuring drug safety, efficacy, quality, or purity?
What is the significance of a drug's label in determining its adulteration?
What is the significance of a drug's label in determining its adulteration?
What is the primary criterion for determining a drug's adulteration?
What is the primary criterion for determining a drug's adulteration?
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