Podcast
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?
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?
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?
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?
How does the notification requirement differ for pharmacies that are part of a chain?
What is the definition of "class I recall" as outlined in the text?
What is the definition of "class I recall" as outlined in the text?
Flashcards are hidden until you start studying
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)
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.