Pharmacy Controlled Substances and DEA Regulations 1 — Questions and Answers
Question 1: Schedule II controlled substances are characterized by:
- No accepted medical use in the US
- High potential for abuse with accepted medical use; no refills allowed (Correct answer)
- Low potential for abuse relative to Schedule III
- Unlimited refills within one year
Correct answer: High potential for abuse with accepted medical use; no refills allowed
Schedule II drugs (e.g., oxycodone, amphetamine, fentanyl) have high abuse potential, accepted medical uses, and may lead to severe psychological or physical dependence. No refills are permitted.
Question 2: Which DEA form is used to order Schedule I and II controlled substances?
- DEA Form 41
- DEA Form 106
- DEA Form 222 (or CSOS electronically) (Correct answer)
- DEA Form 363
Correct answer: DEA Form 222 (or CSOS electronically)
DEA Form 222 (paper) or CSOS (Controlled Substance Ordering System, electronic) is required to order Schedule I and II controlled substances from a distributor.
Question 3: A DEA number always begins with two letters. The second letter is always:
- The first letter of the state where the prescriber practices
- The first letter of the prescriber's last name (Correct answer)
- A random check-digit letter assigned by the DEA
- The letter of the drug schedule the prescriber is authorized to prescribe
Correct answer: The first letter of the prescriber's last name
DEA numbers follow the format: letter (A/B/F/M/etc.) + first letter of registrant's last name + 7 digits. The second character is the first letter of the registrant's last name.
Question 4: Emergency oral dispensing of a Schedule II controlled substance without a written prescription is permitted ONLY if:
- The quantity is limited to a 30-day supply maximum
- An oral authorization is given and a written prescription is delivered to the pharmacy within 7 days (Correct answer)
- The patient is in a hospital setting
- The drug is dispensed free of charge
Correct answer: An oral authorization is given and a written prescription is delivered to the pharmacy within 7 days
Under 21 CFR 1306.11(d), a pharmacist may dispense a Schedule II in a genuine emergency on an oral order, but the prescriber must provide a written/electronic prescription within 7 days.
Question 5: DEA Form 41 is used when a pharmacy needs to:
- Order Schedule II controlled substances
- Report the theft of controlled substances
- Destroy outdated or unneeded controlled substances (Correct answer)
- Transfer a DEA registration to a new location
Correct answer: Destroy outdated or unneeded controlled substances
DEA Form 41 (Registrant Record of Controlled Substances Destroyed) is used to document the destruction of controlled substances at the registrant's registered location.
Question 6: Which of the following is a Schedule V controlled substance?
- Hydrocodone (single-entity)
- Codeine combination products with ≤200 mg/100 mL (e.g., cough syrup) (Correct answer)
- Alprazolam (Xanax)
- Oxycodone (OxyContin)
Correct answer: Codeine combination products with ≤200 mg/100 mL (e.g., cough syrup)
Codeine-containing cough preparations with ≤200 mg of codeine per 100 mL (e.g., Robitussin AC) are Schedule V. Hydrocodone single-entity and oxycodone are Schedule II; alprazolam is Schedule IV.
Pharmacy Controlled Substances and DEA Regulations 1
Schedule II controlled substances are characterized by: