CCP Regulatory Compliance 3 — Questions and Answers
Question 1: Which DEA form is used to report the theft or significant loss of controlled substances from a pharmacy?
- DEA Form 222
- DEA Form 41
- DEA Form 106 (Correct answer)
- DEA Form 363
Correct answer: DEA Form 106
DEA Form 106 must be completed and submitted to report theft or significant loss of controlled substances.
Question 2: The Risk Evaluation and Mitigation Strategy (REMS) program is administered by which agency?
- DEA
- CMS
- FDA (Correct answer)
- SAMHSA
Correct answer: FDA
The FDA administers REMS programs to ensure benefits of certain drugs outweigh their risks.
Question 3: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit for pseudoephedrine products per purchaser?
- 3.6 grams (Correct answer)
- 6 grams
- 9 grams
- 12 grams
Correct answer: 3.6 grams
CMEA limits daily pseudoephedrine sales to 3.6 grams per purchaser and 9 grams per 30-day period.
Question 4: A nursing facility resident's medication regimen is reviewed and a potentially inappropriate medication is identified per the Beers Criteria. This review is BEST classified as:
- Retrospective drug utilization review (Correct answer)
- Prospective drug utilization review
- Concurrent drug utilization review
- Pharmacovigilance reporting
Correct answer: Retrospective drug utilization review
Monthly medication regimen reviews in LTC are retrospective DUR, evaluating medications already dispensed.
Question 5: Which federal law established the Prescription Drug Monitoring Program (PDMP) grant funding to states?
- Harold Rogers Prescription Drug Monitoring Program (Correct answer)
- Ryan Haight Online Pharmacy Consumer Protection Act
- Drug Quality and Security Act
- Controlled Substances Act
Correct answer: Harold Rogers Prescription Drug Monitoring Program
The Harold Rogers PDMP provides federal grant funding to states to establish and enhance prescription drug monitoring programs.
Question 6: Which CMS condition of participation requires a hospital pharmacy to have a pharmacist available or on call at all times?
- 482.25 - Pharmaceutical Services (Correct answer)
- 482.13 - Patient Rights
- 482.21 - Quality Assessment
- 482.43 - Discharge Planning
Correct answer: 482.25 - Pharmaceutical Services
42 CFR 482.25 specifies that hospital pharmaceutical services must ensure a pharmacist is available or on call 24/7.
Question 7: Under the Drug Supply Chain Security Act (DSCSA), pharmacies must be able to trace prescription drug products for how many years?
- 2 years
- 3 years (Correct answer)
- 5 years
- 7 years
Correct answer: 3 years
DSCSA requires pharmacies to maintain transaction documentation and tracing records for 3 years.
CCP Regulatory Compliance 3
Which DEA form is used to report the theft or significant loss of controlled substances from a pharmacy?