Free Multistate Pharmacy Jurisprudence Examination (MPJE) Controlled Substances Regulations Questions and Answers — Questions and Answers
Question 1: A pharmacy orders 10 bottles of oxycodone 10 mg tablets using a DEA Form 222. The supplier ships 7 bottles and annotates the form accordingly. According to federal law, what is the maximum time the supplier has to send the remaining 3 bottles before the order form becomes invalid for that line item?
- 30 days from the date of the partial shipment
- 90 days from the date the form was executed
- 60 days from the date the form was executed (Correct answer)
- 14 business days from the partial shipment
Correct answer: 60 days from the date the form was executed
According to 21 CFR 1305.13(b), if a supplier cannot fill an entire order for a Schedule II substance, they may fill it in part and supply the remaining balance through additional shipments within 60 days of the date on the DEA Form 222. After 60 days, the form is no longer valid for that order.
Question 2: A patient presents a valid prescription for morphine sulfate ER 15 mg, quantity of 60 tablets. The patient states they only want to try a 15-day supply (30 tablets) initially to see if they can tolerate it. Under the Comprehensive Addiction and Recovery Act (CARA) provisions, what is the latest the patient can obtain the remaining 30 tablets?
- Within 72 hours of the partial fill
- Within 30 days from the date the prescription was written (Correct answer)
- Within 7 days of the partial fill
- Within 60 days from the date the prescription was written
Correct answer: Within 30 days from the date the prescription was written
The Comprehensive Addiction and Recovery Act (CARA) amended the Controlled Substances Act to allow for the partial filling of Schedule II prescriptions at the request of the patient or prescriber. The remaining portion must be filled no later than 30 days after the date on which the prescription was written.
Question 3: A pharmacist receives a telephone call from a known local physician for an emergency supply of hydromorphone for a patient in severe pain. Which of the following is a federal requirement for this emergency dispensing situation?
- The pharmacist must receive a written, signed prescription from the prescriber within 30 days.
- The quantity dispensed can be for a maximum of a 30-day supply.
- The prescriber must provide a written prescription, postmarked within 7 days of the oral order. (Correct answer)
- The pharmacist must notify the local DEA field office within 48 hours of dispensing.
Correct answer: The prescriber must provide a written prescription, postmarked within 7 days of the oral order.
Federal regulation 21 CFR 1306.11(d) stipulates that in an emergency situation, a pharmacist may dispense a Schedule II substance upon oral authorization. However, the prescribing practitioner must provide a written prescription for the emergency quantity to the dispensing pharmacist within 7 days. It can be delivered in person or postmarked within the 7-day period.
Question 4: According to federal law, which of the following is a requirement for a pharmacy's biennial controlled substance inventory?
- An exact count is required for all Schedule III, IV, and V substances.
- The inventory must be taken on the same date every two years.
- The inventory record must be submitted to the DEA within 45 days of completion.
- An exact physical count of all Schedule II controlled substances is mandatory. (Correct answer)
Correct answer: An exact physical count of all Schedule II controlled substances is mandatory.
Federal law requires an actual physical count of all Schedule II controlled substances during an inventory. For Schedule III, IV, and V substances, an estimated count is permissible unless the container holds more than 1,000 tablets or capsules, in which case an exact count is required.
Question 5: The pharmacist-in-charge at a community pharmacy discovers a significant loss of zolpidem (Schedule IV) tablets during a routine count. According to federal regulations, what is the initial reporting requirement?
- Complete and submit DEA Form 41 within 24 hours.
- Notify the local police department within 72 hours.
- Notify the nearest DEA Diversion Field Office in writing within one business day of discovery. (Correct answer)
- File a report with the State Board of Pharmacy within 10 business days.
Correct answer: Notify the nearest DEA Diversion Field Office in writing within one business day of discovery.
Federal regulations (21 C.F.R. §1301.76(b)) require that upon discovery of a theft or significant loss of any controlled substance, the registrant must notify the local DEA Diversion Field Office, in writing, within one business day. Following this initial notification, the registrant must complete a DEA Form 106.
Question 6: Under federal law, which of the following is NOT a requirement for a pharmacist to dispense a Schedule V substance without a prescription, where permitted by state law?
- The dispensing must be done only by a pharmacist.
- The purchaser must be at least 18 years of age.
- The pharmacist must obtain authorization from the patient's primary physician. (Correct answer)
- A bound record book must be maintained with details of the sale.
Correct answer: The pharmacist must obtain authorization from the patient's primary physician.
Federal law (21 CFR 1306.26) outlines several requirements for dispensing certain C-V substances over-the-counter. These include that the dispensing is done by a pharmacist, the purchaser is at least 18, and the sale is recorded in a bound book. There is no federal requirement to obtain authorization from the patient's physician for such a transaction.
Free Multistate Pharmacy Jurisprudence Examination (MPJE) Controlled Substances Regulations Questions and Answers
A pharmacy orders 10 bottles of oxycodone 10 mg tablets using a DEA Form 222.
The supplier ships 7 bottles and annotates the form accordingly.
According to federal law, what is the maximum time the supplier has to send the remaining 3 bottles before the order form becomes invalid for that line item?