DEA Controlled Substances Regulations & Scheduling 2 — Questions and Answers
Question 1: Under the Controlled Substances Act, which agency has the authority to initiate scheduling proceedings for a new substance?
- The FDA exclusively
- The DEA, the FDA, or any interested party via petition (Correct answer)
- Congress only, through legislation
- The CDC in coordination with state health departments
Correct answer: The DEA, the FDA, or any interested party via petition
Under 21 U.S.C. § 811, scheduling proceedings can be initiated by the DEA, the FDA, or any interested party who files a petition with the DEA.
Question 2: A Schedule II controlled substance prescription may NOT be refilled. What is the regulatory basis for this restriction?
- 21 CFR 1306.12, which prohibits refills of Schedule II prescriptions (Correct answer)
- The Prescription Drug Monitoring Program Act of 2005
- FDA guidance limiting opioid dispensing
- DEA administrator policy memoranda
Correct answer: 21 CFR 1306.12, which prohibits refills of Schedule II prescriptions
21 CFR 1306.12 explicitly prohibits the refilling of Schedule II controlled substance prescriptions.
Question 3: Which of the following best describes the 'substantial evidence' standard used in DEA scheduling decisions?
- Evidence beyond a reasonable doubt from at least three peer-reviewed studies
- A preponderance of credible scientific evidence supporting the scheduling determination (Correct answer)
- Unanimous agreement among HHS scientific advisors
- Evidence sufficient to convince a federal jury
Correct answer: A preponderance of credible scientific evidence supporting the scheduling determination
The DEA applies a preponderance of credible scientific evidence standard when evaluating whether a substance meets scheduling criteria.
Question 4: A substance with accepted medical use and low-to-moderate physical dependence potential but high psychological dependence potential would be classified as which schedule?
- Schedule I
- Schedule II
- Schedule III (Correct answer)
- Schedule IV
Correct answer: Schedule III
Schedule III substances have accepted medical use and low-to-moderate physical dependence potential but may have high psychological dependence potential.
Question 5: What is the maximum federal penalty for a first-offense trafficking conviction involving 1 kilogram or more of heroin?
- 10 years to life imprisonment and up to $4 million fine (Correct answer)
- 5 to 40 years imprisonment and up to $2 million fine
- Life imprisonment with no possibility of parole
- 20 years to life and up to $8 million fine
Correct answer: 10 years to life imprisonment and up to $4 million fine
Under 21 U.S.C. § 841, trafficking 1 kg or more of heroin carries 10 years to life imprisonment and fines up to $4 million for individuals.
Question 6: Which factor is NOT one of the eight criteria the DEA must consider when scheduling a substance under 21 U.S.C. § 811?
- Its actual or relative potential for abuse
- The substance's country of origin (Correct answer)
- Scientific evidence of its pharmacological effects
- The risk to public health
Correct answer: The substance's country of origin
Country of origin is not among the eight statutory criteria; the CSA focuses on pharmacological, scientific, and public health factors.
Question 7: Under the DEA's regulations, a registered practitioner who dispenses Schedule III-V controlled substances must maintain records for a minimum of how many years?
- 1 year
- 2 years (Correct answer)
- 5 years
- 7 years
Correct answer: 2 years
21 CFR 1304.04 requires registrants to maintain all records related to controlled substances for a minimum of two years.
DEA Controlled Substances Regulations & Scheduling 2
Under the Controlled Substances Act, which agency has the authority to initiate scheduling proceedings for a new substance?