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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.</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.</p> Signup and view all the answers

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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Description

This quiz covers the protocol for pharmacies to follow in the event of a Class I recall of a prescription drug, including notification procedures for affected patients.