Pharmacy Class I Recall Procedure

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Questions and Answers

What is the primary purpose of the notification requirement for pharmacies in the case of a Class I recall of a prescription drug?

  • To prevent any further dispensing of the recalled drug.
  • To ensure that all patients who have been prescribed the recalled drug are notified, regardless of whether they are currently taking it.
  • To comply with regulations from the United States Food and Drug Administration. (correct)
  • To protect the pharmacy from legal liability in the event of adverse health consequences.

Under which circumstance would a pharmacy be required to notify patients about a recalled prescription drug?

  • When a manufacturer issues a voluntary recall of a drug.
  • When a patient reports experiencing adverse effects after taking a prescribed drug.
  • When a wholesaler informs the pharmacy of a potential contamination issue with a drug.
  • When the United States Food and Drug Administration issues a Class II recall. (correct)

What is the maximum timeframe allowed for a pharmacy to notify patients after receiving notice of a Class I recall?

  • 24 hours
  • 1 week
  • 72 hours (correct)
  • 48 hours

How does the notification requirement differ for pharmacies that are part of a chain?

<p>Chain pharmacies can use a central office to notify patients. (C)</p> Signup and view all the answers

What is the definition of "class I recall" as outlined in the text?

<p>A recall of a drug that poses a serious risk of adverse health consequences or death. (C)</p> Signup and view all the answers

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Study Notes

Class I Recall

  • A class I recall occurs when the US FDA determines that a product has a reasonable probability of causing serious adverse health consequences or death.

Prescription Drug Recall Notification

  • In the event of a class I recall of a prescription drug, pharmacies must make a reasonable attempt to notify patients who: • Have been prescribed the recalled drug • Are currently taking the recalled drug • Received the drug from the pharmacy
  • Notification must be made within three days of the pharmacy being notified of the recall by: • The US FDA • A manufacturer • A wholesaler • Other notice of the recall
  • Notification can be provided by: • An individual pharmacy • A central office (in the case of a pharmacy chain)

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