8 Federal Pharmacy Compliance Practice Cases Free Online FlashCards

Can a Schedule II prescription be refilled?

Schedule II prescriptions cannot be refilled under federal law.

What are the initial steps after finding a controlled-substance count discrepancy?

Secure the stock and records, promptly investigate and document the discrepancy, and notify appropriate pharmacy leadership.

How should a pharmacy identify stock affected by a lot-specific recall?

Compare the recall notice with the product and lot numbers on hand to identify matching stock.

What health risks distinguish FDA recall Classes I, II, and III?

Class I: reasonable probability of serious harm or death. Class II: possible temporary or medically reversible harm, or remote probability of serious harm. Class III: unlikely to cause adverse health consequences.

When may a pharmacy dispense a REMS drug requiring verification?

Do not dispense until the pharmacy meets the applicable REMS requirements and completes the required verification.

Does a patient’s report of the prescriber’s intent authorize a Schedule II refill?

No. A patient’s report of the prescriber’s intent does not change the prescription on file or authorize a refill.

What federal reporting applies to controlled-substance theft or significant loss?

If the event is theft or significant loss, federal rules require reporting it to DEA and submitting DEA Form 106; follow the applicable procedures and timelines.

Does every small unexplained count discrepancy automatically have the same reporting outcome?

No. Do not assume every small unexplained discrepancy has the same reporting outcome; document the facts and promptly determine whether it is theft or significant loss.

What should a pharmacy do with matching stock during a recall?

Quarantine matching stock so it cannot be dispensed.

How should a pharmacy handle quarantined recalled stock?

Follow the recall instructions for return or other disposition, and document the actions taken.

How can a pharmacy identify and respond to patients who may have received a recalled lot?

Use dispensing records to identify potentially affected patients, then follow the notice’s directions for communication and coordination with prescribers.

What should a pharmacy do if its records cannot distinguish the recalled lot?

Seek guidance from the manufacturer and relevant health authorities rather than assuming no patients were affected.