Consumer Product Packaging Regulations
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Questions and Answers

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?

  • 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?

  • 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?

    <p>To address situations where tests or methods of assay as prescribed are insufficient.</p> Signup and view all the answers

    What is the criteria for a drug to be deemed adulterated under paragraph (c)?

    <p>If its safety, efficacy, quality, or purity falls below that which it purports or is represented to possess.</p> Signup and view all the answers

    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?

    <p>The drug or device is deemed adulterated.</p> Signup and view all the answers

    What is the relevance of an official compendium in determining a drug's adulteration?

    <p>It sets the standards for drug safety, efficacy, quality, or purity.</p> Signup and view all the answers

    What is the role of the Department in ensuring drug safety, efficacy, quality, or purity?

    <p>It promulgates regulations prescribing appropriate tests or methods of safety, efficacy, quality, or purity.</p> Signup and view all the answers

    What is the significance of a drug's label in determining its adulteration?

    <p>It explicitly states the drug's difference in strength, safety, efficacy, quality, or purity from the standards set forth in an official compendium.</p> Signup and view all the answers

    What is the primary criterion for determining a drug's adulteration?

    <p>Its strength, safety, efficacy, quality, or purity compared to the standards set forth in an official compendium.</p> Signup and view all the answers

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