MPJE Federal Controlled Substances Act Questions and Answers — Questions and Answers
Question 1: A pharmacy must conduct a biennial inventory of all controlled substances on hand. According to federal law, which of the following statements is correct regarding the counting requirements for this inventory?
- All Schedule II substances must be exactly counted, and all Schedule III-V substances may be estimated.
- An exact count is required for all open containers of Schedule III, IV, or V substances holding more than 1,000 dosage units. (Correct answer)
- All controlled substances, regardless of schedule, can be estimated as long as the container holds less than 500 units.
- The inventory requires an exact count for all Schedule II-V controlled substances, without exception.
Correct answer: An exact count is required for all open containers of Schedule III, IV, or V substances holding more than 1,000 dosage units.
Federal law (21 CFR §1304.11) requires an exact count for all Schedule I and II controlled substances. For Schedule III, IV, and V substances, an estimated count is permissible for opened containers, unless the container holds more than 1,000 tablets or capsules, in which case an exact count is required.
Question 2: A pharmacist receives a legitimate, written prescription for oxycodone 10mg. All required information is present except for the date of issue, which the prescriber omitted. According to federal law, what is the most appropriate action for the pharmacist to take?
- Return the prescription to the patient and inform them it is invalid and must be re-written.
- Add the current date to the prescription, as it was presented on this day, and then dispense it.
- Dispense the medication and document on the hard copy that the date was missing.
- Contact the prescriber to obtain the date of issue, document the conversation and the date on the prescription, and then dispense. (Correct answer)
Correct answer: Contact the prescriber to obtain the date of issue, document the conversation and the date on the prescription, and then dispense.
A prescription for a controlled substance must be dated as of the date of issue. While a pharmacist cannot change fundamental information like the patient's name, the drug prescribed (except for generic substitution), or the prescriber's signature, federal guidance allows pharmacists to contact the prescriber to add or clarify information such as the issue date after verification. This action must be properly documented on the prescription.
Question 3: Upon discovering a significant loss of a Schedule IV controlled substance, a pharmacy is required to take which of the following actions within one business day?
- Complete and submit a DEA Form 106 to the local DEA office.
- Notify the local DEA Diversion Field Office in writing. (Correct answer)
- Conduct a complete physical inventory of all controlled substances.
- Notify the state board of pharmacy and the local police.
Correct answer: Notify the local DEA Diversion Field Office in writing.
According to 21 CFR §1301.76(b), a registrant must notify the local DEA Diversion Field Office, in writing, of any theft or significant loss of any controlled substances within one business day of discovery. While completing a DEA Form 106 is also required, the initial notification must happen within one business day, and the form itself has a longer submission deadline (45 days).
Question 4: Which DEA form is required for a pharmacy to order Schedule II controlled substances like fentanyl and methylphenidate from a distributor?
- DEA Form 41
- DEA Form 222 (Correct answer)
- DEA Form 106
- DEA Form 224
Correct answer: DEA Form 222
DEA Form 222 is the official order form for Schedule I and II controlled substances. A pharmacy must use this form (or its electronic equivalent, CSOS) to purchase these substances. DEA Form 41 is for disposal, Form 106 is for reporting theft or loss, and Form 224 is the registration application for pharmacies.
Question 5: Under the provisions of the Comprehensive Addiction and Recovery Act (CARA) amending the Controlled Substances Act, a patient may request a partial fill of a Schedule II prescription. If a partial fill is dispensed, any remaining quantity must be filled no later than:
- 72 hours from the date the prescription was written.
- 7 days from the date of the partial fill.
- 30 days from the date the prescription was written. (Correct answer)
- 60 days from the date of the partial fill.
Correct answer: 30 days from the date the prescription was written.
The Comprehensive Addiction and Recovery Act (CARA) amended the CSA to allow for partial filling of Schedule II prescriptions at the request of the patient or prescriber. The law specifies that the remaining portions of a partially filled prescription must be filled no later than 30 days after the date on which the prescription was written.
Question 6: According to the federal Controlled Substances Act, how long must a pharmacy maintain all required records, including prescriptions and inventory records, for inspection and copying by authorized DEA officials?
- 10 years
- 7 years
- 5 years
- 2 years (Correct answer)
Correct answer: 2 years
Federal regulation 21 CFR §1304.04(a) mandates that every inventory or other record required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or record, for inspection and copying by authorized employees of the Administration. State laws may require a longer period, but the federal minimum is two years.
MPJE Federal Controlled Substances Act Questions and Answers
A pharmacy must conduct a biennial inventory of all controlled substances on hand.
According to federal law, which of the following statements is correct regarding the counting requirements for this inventory?