CFPN Pharmacy Law and Regulatory Compliance 2 — Questions and Answers
Question 1: An emergency oral prescription for a Schedule II controlled substance may be dispensed in what quantity?
- Up to a 30-day supply
- Up to a 15-day supply
- Only enough to cover the emergency period, typically a 72-hour supply (Correct answer)
- Up to a 7-day supply
Correct answer: Only enough to cover the emergency period, typically a 72-hour supply
Emergency oral prescriptions for Schedule II controlled substances may only be dispensed in a quantity sufficient for the emergency period, generally limited to a 72-hour supply.
Question 2: Under the Drug Supply Chain Security Act (DSCSA), which key requirement helps prevent counterfeit medications from entering the pharmaceutical supply chain?
- Mandatory electronic prescribing for all controlled substances
- Track-and-trace serialization of prescription drug products (Correct answer)
- Mandatory DEA drug testing of all pharmacy personnel
- Random FDA inspections of retail and hospital pharmacies
Correct answer: Track-and-trace serialization of prescription drug products
The DSCSA requires serialization and track-and-trace systems to verify the integrity of prescription drugs at each point in the supply chain from manufacturer to patient.
Question 3: A pharmacist discovers a significant discrepancy in the perpetual inventory of a Schedule II controlled substance. The DEA must be notified within:
- One business day of discovery (Correct answer)
- Three business days of discovery
- 72 hours of discovery
- 14 days of discovery
Correct answer: One business day of discovery
Significant losses or thefts of Schedule II controlled substances must be reported to the DEA on DEA Form 106 within one business day of discovery.
Question 4: Which act created the waiver system allowing qualified physicians to prescribe buprenorphine for opioid use disorder treatment in office-based settings?
- Harrison Narcotic Tax Act
- Drug Addiction Treatment Act (DATA) of 2000 (Correct answer)
- Controlled Substances Act
- Combat Methamphetamine Epidemic Act
Correct answer: Drug Addiction Treatment Act (DATA) of 2000
The Drug Addiction Treatment Act (DATA) of 2000 created the waiver system allowing qualified physicians to obtain a DEA waiver to prescribe buprenorphine for opioid use disorder.
Question 5: When a pharmacist suspects a prescription for a controlled substance is fraudulent, what is the most appropriate course of action?
- Dispense the medication and report the suspicion to the prescriber afterward
- Refuse to fill, document the refusal, contact the prescriber, and notify law enforcement if criminal activity is suspected (Correct answer)
- Confiscate the prescription and immediately file a DEA report
- Dispense a partial supply and hold the remainder pending verification
Correct answer: Refuse to fill, document the refusal, contact the prescriber, and notify law enforcement if criminal activity is suspected
A pharmacist who suspects a fraudulent prescription should refuse to dispense, document the incident, attempt prescriber verification, and notify law enforcement when criminal activity is reasonably suspected.
Question 6: The Federal Analog Act extends scheduling control to substances that are substantially similar to scheduled drugs in which way?
- Chemical structure only
- Pharmacological effect only
- Chemical structure or pharmacological effect, when intended for human consumption (Correct answer)
- Trade name or physical appearance
Correct answer: Chemical structure or pharmacological effect, when intended for human consumption
The Federal Analog Act controls substances substantially similar to a scheduled drug in chemical structure or pharmacological effect when those substances are intended for human consumption.
Question 7: A DEA registration number for a physician begins with the letter 'A' or 'B'. What does the first letter of a DEA number typically signify?
- The state where the physician is licensed
- The type of DEA registrant (e.g., practitioner, hospital) (Correct answer)
- The year the DEA registration was issued
- The schedules of controlled substances authorized
Correct answer: The type of DEA registrant (e.g., practitioner, hospital)
The first letter of a DEA registration number indicates the type of registrant, such as 'A' or 'B' for practitioners, 'M' for mid-level practitioners, and 'P' or 'R' for distributors.
CFPN Pharmacy Law and Regulatory Compliance 2
An emergency oral prescription for a Schedule II controlled substance may be dispensed in what quantity?