Pharmacist Licensure, Covering Federal and State Pharmacy Laws,
DEA Regulations, Controlled Substances, Prescription
Requirements, Pharmacist Responsibilities and Regulatory
Compliance
Question 1
A pharmacist receives a phone call from a prescriber's office requesting a refill authorization
for a Schedule IV medication. The prescriber's agent (a medical assistant) states the
physician has authorized the refill but is currently in surgery. Under federal law, which of the
following statements is most accurate regarding this situation?
A. The pharmacist may accept the refill authorization from the agent because Schedule IV
medications may be refilled orally by an authorized agent.
B. The pharmacist must refuse the refill until the prescriber personally authorizes it, as
agents may not communicate Schedule IV refills.
C. The pharmacist may accept the authorization only if the agent provides the prescriber's
DEA registration number.
D. The pharmacist must require a new written prescription because Schedule IV medications
cannot be refilled.
Correct Answer: A
Explanation:
Federal DEA regulations permit a prescriber's authorized agent to communicate refill
authorizations for Schedule III–V controlled substances, provided the agent is acting under
the prescriber's direction and the prescription is otherwise valid. Schedule II prescriptions
cannot be refilled and require direct prescriber communication for emergency oral orders.
,Question 2
A patient presents a prescription for a Schedule II stimulant dated 45 days ago. The patient
states they were traveling and could not fill it sooner. The prescription is otherwise valid and
the pharmacist confirms it was issued for a legitimate medical purpose. Which of the
following best describes the pharmacist's authority to dispense under federal law?
A. The pharmacist must refuse to fill because Schedule II prescriptions expire after 30 days
under federal law.
B. The pharmacist may dispense because federal law does not impose a specific expiration
date on Schedule II prescriptions.
C. The pharmacist must refuse because prescriptions older than 14 days are invalid for
controlled substances.
D. The pharmacist may dispense only if the prescriber provides a new prescription with a
current date.
Correct Answer: B
Explanation:
Federal law does not mandate an expiration date for Schedule II prescriptions; however,
many states impose time limits (e.g., 30, 60, or 90 days). The pharmacist must follow the
stricter of federal or state law. A prescription lacking a state-mandated fill window would still
be valid federally.
Question 3
A pharmacy technician discovers that 50 dosage units of oxycodone 30 mg tablets are
missing from inventory. The pharmacist-in-charge determines the loss was due to employee
theft. Which DEA form is required to report this significant loss?
A. DEA Form 222
B. DEA Form 106
,C. DEA Form 41
D. DEA Form 224
Correct Answer: B
Explanation:
DEA Form 106 is used to report theft or significant loss of controlled substances. Form 222 is
for ordering Schedule I/II substances. Form 41 documents destruction. Form 224 is for
pharmacy registration. Theft must also be reported to local law enforcement and the state
board as applicable.
Question 4
A physician calls in an emergency oral prescription for fentanyl 50 mcg/hr patches for a
hospice patient in acute pain. The pharmacist dispenses a limited quantity. Under federal
regulations, within what time frame must the prescriber provide a written or electronic
prescription to the pharmacy?
A. 24 hours
B. 72 hours
C. 7 days
D. 14 days
Correct Answer: C
Explanation:
For emergency oral Schedule II prescriptions, federal law requires the prescriber to deliver a
written, electronic, or faxed prescription to the pharmacy within 7 days. The pharmacist
must document the emergency circumstances and make a reasonable effort to verify the
prescriber's authority.
, Question 5
A pharmacy receives a shipment of a new brand of albuterol inhalers. The wholesaler is not
on the pharmacy's usual trading partner list, and the price is significantly below market.
Upon inspection, the pharmacist notices the product labeling lacks the National Drug Code
and the lot number is obscured. Which federal law is most directly implicated by this
scenario?
A. The Controlled Substances Act
B. The Drug Supply Chain Security Act (DSCSA)
C. The Poison Prevention Packaging Act
D. The Health Insurance Portability and Accountability Act (HIPAA)
Correct Answer: B
Explanation:
The DSCSA establishes requirements for the distribution of prescription drugs, including
verification of trading partners, product tracing, and detection of suspect or illegitimate
products. Missing NDC and obscured lot numbers are red flags for counterfeit or diverted
product. Pharmacists must quarantine suspect product and follow verification protocols.
Question 6
A patient requests that a pharmacist substitute a generic for a brand-name thyroid
medication. The prescriber wrote "Brand Medically Necessary" on the prescription. Under
state law, which of the following is the pharmacist's most appropriate action?
A. Substitute the generic because patient request always overrides prescriber instructions.
B. Refuse to substitute because the prescriber explicitly indicated brand necessity.
C. Dispense the brand and bill the patient the generic copay as a courtesy.
D. Contact the prescriber to request permission to substitute despite the notation.