& Detailed Rationales, New York Pharmacy Law, Federal
Regulations, Controlled Substances, Pharmacist Licensure,
Prescription Dispensing & Pharmacy Operations
Section 1: Federal Controlled Substances Act (CSA) — Registration, Schedules, and Ordering
1. A pharmacy's DEA registration expires on June 30. The pharmacy submits a renewal
application on July 15. Under federal law, what is the pharmacy's legal status regarding
controlled substance dispensing during the gap period?
A. The pharmacy may continue dispensing Schedule II–V substances under an automatic 30-
day grace period.
B. The pharmacy may dispense only Schedule III–V substances until renewal is processed.
C. The pharmacy must cease all controlled substance dispensing until the DEA issues a new
registration.
D. The pharmacy may dispense controlled substances only for emergency prescriptions
during the gap.
Correct Answer: C
Explanation: DEA registrations are not retroactive; once expired, controlled substance
activity must cease until renewal is approved.
2. A DEA investigator requests to see a pharmacy's controlled substance order forms. For
which schedule(s) must the pharmacy retain DEA Form 222 copies for two years?
A. Schedule II only
B. Schedules II and III
C. Schedules II, III, IV, and V
D. Schedules I and II
,Correct Answer: A
Explanation: DEA Form 222 is required only for Schedule I and II controlled substances.
Schedules III–V use invoices.
3. Which federal schedule classification includes drugs with a currently accepted medical use
in treatment in the United States and a moderate-to-low potential for physical dependence?
A. Schedule I
B. Schedule II
C. Schedule III
D. Schedule V
Correct Answer: C
Explanation: Schedule III substances have accepted medical use and moderate/low
dependence potential, distinguishing them from Schedules I, II, and V.
4. A pharmacy receives a DEA Form 222 for a Schedule II controlled substance order. The
pharmacy notices the form has a single item error in the package size field. What is the
pharmacy's best course of action?
A. Fill the order as written and correct the error on the pharmacy's copy.
B. Return the entire form to the supplier with a notation of the error.
C. Do not alter the form; cancel the erroneous line and fill remaining lines.
D. Contact the DEA field office for verbal authorization to correct the form.
Correct Answer: C
,Explanation: DEA Form 222 errors must not be altered; the erroneous line is cancelled, and
remaining valid lines may be filled.
5. A pharmacy's DEA registration was suspended for three months following an
administrative hearing. Which activity is the pharmacy prohibited from conducting during
the suspension?
A. Dispensing controlled substances pursuant to valid prescriptions
B. Ordering controlled substances from a distributor
C. Destroying expired controlled substances on-site
D. Both A and B
Correct Answer: D
Explanation: A suspended DEA registration prohibits all controlled substance activity,
including dispensing and ordering.
6. Which of the following individuals may apply for a DEA registration to dispense controlled
substances?
A. A pharmacy intern with a limited permit
B. A physician assistant with prescriptive authority
C. A registered pharmacy technician
D. A pharmacy owner who is not a licensed pharmacist
Correct Answer: B
Explanation: Practitioners authorized to prescribe (including PAs with prescriptive authority)
may obtain DEA registrations; pharmacy owners must be licensed.
, 7. A pharmacy's DEA registration is held by the corporation that owns the pharmacy. The
pharmacy relocates to a new address within the same city. What action must the pharmacy
take regarding its DEA registration?
A. No action; the registration is valid for the corporation regardless of location.
B. Apply for a modification of registration at least 14 days before the move.
C. Submit a new DEA application within 30 days after the move.
D. Notify the state board only; DEA registration is location-independent.
Correct Answer: B
Explanation: DEA regulations require notification and modification at least 14 days prior to
relocation of registered premises.
8. Which federal agency is responsible for scheduling controlled substances under the CSA?
A. Food and Drug Administration (FDA)
B. Drug Enforcement Administration (DEA)
C. Department of Health and Human Services (HHS)
D. Bureau of Narcotic Enforcement (BNE)
Correct Answer: B
Explanation: The DEA has authority to schedule substances under the CSA, though HHS
provides scientific recommendations.
9. A pharmacy's DEA registration is up for renewal. How often must a DEA registration be
renewed?