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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)?
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?
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?
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?
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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)?
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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?
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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?
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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?
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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?
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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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