MPJE 2025 - Pharmacy Operations (Questions &
Answers 2025)
1. What are the record-keeping requirements for non-controlled prescriptions?
Answer:
• Federal: Maintain for 2 years (minimum).
• State Variations: Some states (e.g., Florida) require longer retention (e.g., 4-5 years).
2. Can a pharmacist transfer a C-III to C-V prescription to another pharmacy?
Answer:
• Federal: Yes, one-time transfers are allowed (both pharmacies must maintain records).
• State Variations: Some states prohibit transfers (e.g., Texas for C-V).
3. What is the DEA’s new telehealth rule for controlled substances (2023-2025)?
Answer:
• Ryan Haight Act Exception: Temporary telehealth flexibilities for buprenorphine
(MAT) and non-narcotic C-III-V continue through 2024.
• In-Person Exam Requirement: Still applies for C-II opioids (no permanent telehealth
allowance).
4. What are the USP <800> hazardous drug (HD) handling requirements?
Answer:
• Mandatory: HDs must be stored in negative-pressure areas with SPD (secondary
protective devices).
• Personnel Training: Annual competency assessments required.
5. True or False: Pharmacies must report all controlled substance thefts to the DEA within 24
hours.
Answer: False – Must report significant losses (e.g., >1% of annual CS volume) within 1
business day (DEA Form 106).
6. What is the FDA’s REMS program, and which drugs commonly require it?
Answer:
Answers 2025)
1. What are the record-keeping requirements for non-controlled prescriptions?
Answer:
• Federal: Maintain for 2 years (minimum).
• State Variations: Some states (e.g., Florida) require longer retention (e.g., 4-5 years).
2. Can a pharmacist transfer a C-III to C-V prescription to another pharmacy?
Answer:
• Federal: Yes, one-time transfers are allowed (both pharmacies must maintain records).
• State Variations: Some states prohibit transfers (e.g., Texas for C-V).
3. What is the DEA’s new telehealth rule for controlled substances (2023-2025)?
Answer:
• Ryan Haight Act Exception: Temporary telehealth flexibilities for buprenorphine
(MAT) and non-narcotic C-III-V continue through 2024.
• In-Person Exam Requirement: Still applies for C-II opioids (no permanent telehealth
allowance).
4. What are the USP <800> hazardous drug (HD) handling requirements?
Answer:
• Mandatory: HDs must be stored in negative-pressure areas with SPD (secondary
protective devices).
• Personnel Training: Annual competency assessments required.
5. True or False: Pharmacies must report all controlled substance thefts to the DEA within 24
hours.
Answer: False – Must report significant losses (e.g., >1% of annual CS volume) within 1
business day (DEA Form 106).
6. What is the FDA’s REMS program, and which drugs commonly require it?
Answer:
