TL;DR
Study FDA drug recall classifications, Risk Evaluation and Mitigation Strategies (REMS), and pharmacy responsibilities during recalls. Understanding regulatory safety programs protects patients and is tested on the PTCB Pharmacy Technician Certification.
Free FDA Recalls & REMS Programs Practice Questions
PTCB Pharmacy Technician Certification · Federal Requirements
This module covers FDA Recalls & REMS Programs as part of the Federal Requirements section, testing your understanding of core concepts and their practical application.
| Exam | PTCB Pharmacy Technician Certification |
| Pass Rate | 72% |
| Duration | 120 minutes |
| Module | FDA Recalls & REMS Programs |
Why FDA Recalls & REMS Programs matters
FDA Recalls & REMS Programs is a commonly tested topic on the PTCB Pharmacy Technician Certification because it covers fundamental knowledge required for competent professional practice.
Sample Practice Questions (5)
1. A pharmacy technician finds a product on the shelf that has been included in a Class I recall. What is the FIRST action?
- Immediately remove the product from the shelf and quarantine it
- Continue dispensing until current stock is depleted
- Return it to the manufacturer without notification
- Place a warning label on the product and continue dispensing
2. An FDA "market withdrawal" differs from a recall in that:
- It is a voluntary action by the manufacturer for a minor violation that would not warrant FDA legal action
- It is mandated by the FDA for the most dangerous products
- It applies only to controlled substances
- It requires congressional approval
3. Under the iPLEDGE REMS program, a female patient of childbearing potential must obtain isotretinoin within how many days of the dispensing window?
- 7 days of the pregnancy test and prescription authorization
- 30 days of the initial office visit
- 14 days of the pregnancy test
- 3 days of obtaining the prescription
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Start practicing free →4. The iPLEDGE program is a REMS for which medication?
- Isotretinoin (Accutane/Absorica)
- Clozapine (Clozaril)
- Thalidomide (Thalomid)
- Methadone
5. An FDA Class II recall means the product:
- May cause temporary or medically reversible adverse health consequences
- Will cause death or serious injury
- Is unlikely to cause any adverse health consequences
- Has already been removed from the market permanently
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