DEA Controlled Substances Regulations & Scheduling 3 — Questions and Answers
Question 1: The Analog Act (21 U.S.C. § 813) treats a chemical analog of a Schedule I or II substance as a Schedule I substance when intended for what purpose?
- Industrial manufacturing
- Agricultural pest control
- Human consumption (Correct answer)
- Veterinary use only
Correct answer: Human consumption
The Federal Analog Act treats substances chemically similar to Schedule I or II substances as Schedule I controlled substances when intended for human consumption.
Question 2: Which DEA form must a practitioner use to report the theft or significant loss of controlled substances?
- DEA Form 106 (Correct answer)
- DEA Form 222
- DEA Form 41
- DEA Form 363
Correct answer: DEA Form 106
DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances) must be filed when a registrant experiences theft or significant loss.
Question 3: A pharmacist receives an oral prescription for a Schedule III controlled substance. Under DEA regulations, within how many days must the pharmacist reduce the oral authorization to writing?
- 24 hours
- 48 hours
- 72 hours
- 7 days (Correct answer)
Correct answer: 7 days
Under 21 CFR 1306.21, oral prescriptions for Schedule III-V substances must be promptly reduced to writing; DEA regulations allow up to 7 days.
Question 4: Which of the following is a key distinction between the Controlled Substances Act's 'registration' requirement and a state pharmacy license?
- DEA registration is required only for Schedule II substances, while state licenses cover all schedules
- DEA registration is a federal requirement authorizing handling of controlled substances, while state licenses authorize general pharmacy practice (Correct answer)
- DEA registration replaces the need for a state pharmacy license in federal facilities
- State pharmacy licenses automatically confer DEA registration privileges
Correct answer: DEA registration is a federal requirement authorizing handling of controlled substances, while state licenses authorize general pharmacy practice
DEA registration under the CSA is a separate federal authorization for controlled substance activities, distinct from and in addition to state licensing requirements.
Question 5: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily purchase limit for ephedrine or pseudoephedrine products per individual?
- 3.6 grams (Correct answer)
- 7.2 grams
- 9 grams
- 12 grams
Correct answer: 3.6 grams
The CMEA limits purchases to 3.6 grams of ephedrine/pseudoephedrine base per day and 9 grams per 30-day period.
Question 6: Which of the following correctly describes an 'emergency dispensing' situation allowing a pharmacist to dispense Schedule II substances without a written prescription?
- The pharmacist believes the patient may be at risk of harm if not treated immediately, and the prescriber cannot be reached
- Immediate administration is necessary, the quantity is limited to the emergency period, and a written prescription follows within 7 days (Correct answer)
- The patient presents a valid Schedule III prescription and requests a stronger medication
- A physician's assistant calls in the prescription and agrees to fax it within 24 hours
Correct answer: Immediate administration is necessary, the quantity is limited to the emergency period, and a written prescription follows within 7 days
Under 21 CFR 1306.11(d), emergency Schedule II oral prescriptions require that immediate administration is necessary, only a limited quantity is dispensed, and a written prescription is provided within 7 days.
Question 7: What does the term 'diversion' mean in the context of the DEA's Diversion Control Division?
- The legal transfer of controlled substances between DEA registrants
- The rerouting of legitimately manufactured controlled substances into illicit channels (Correct answer)
- The scheduling of a substance from a higher to a lower schedule
- The international import/export of precursor chemicals
Correct answer: The rerouting of legitimately manufactured controlled substances into illicit channels
Diversion refers to the transfer of legally manufactured controlled substances from their intended lawful use into illegal channels for non-medical purposes.
DEA Controlled Substances Regulations & Scheduling 3
The Analog Act (21 U.S.C. § 813) treats a chemical analog of a Schedule I or II substance as a Schedule I substance when intended for what purpose?