PTCE Pharmacy Law and Regulations 4

Question 1

Which of the following best describes the role of the State Board of Pharmacy?

Accepted Answer

Licenses pharmacists and regulates pharmacy practice within the state

Answer

Sets federal drug scheduling

Answer

Approves new drug applications

Answer

Enforces DEA controlled substance quotas

Question 2

Under the DSCSA (Drug Supply Chain Security Act), pharmacies must be able to trace a recalled drug product back through how many prior transactions?

Accepted Answer

The entire supply chain back to the manufacturer

Answer

One transaction only

Answer

Three transactions

Answer

Six transactions

Question 3

A prescription for alprazolam (Schedule IV) is presented 4 months after it was written. The technician should:

Accepted Answer

Refuse — it has exceeded the 6-month validity period

Answer

Fill it — Schedule IV prescriptions are valid for 12 months

Answer

Fill it — Schedule IV has no expiration date

Answer

Transfer it to another pharmacy for verification

Question 4

Which of the following is an example of a medication error category under the NCC MERP index classified as 'Category E'?

Accepted Answer

Error contributed to temporary harm requiring intervention

Answer

Error did not reach the patient

Answer

Error reached the patient but caused no harm

Answer

Error contributed to permanent harm

Question 5

Which law established the Risk Evaluation and Mitigation Strategies (REMS) program?

Accepted Answer

Food and Drug Administration Amendments Act (FDAAA) of 2007

Answer

Medicare Modernization Act

Answer

Kefauver-Harris Amendment

Answer

Hatch-Waxman Act

Question 6

A pharmacy technician may accept a new oral prescription order ONLY if:

Accepted Answer

The prescriber calls directly and the pharmacist is present to take it over immediately

Answer

The technician is nationally certified (CPhT)

Answer

The state board allows technicians to take verbal orders independently

Answer

The prescription is for a non-controlled substance

Question 7

The Kefauver-Harris Amendment of 1962 added which requirement for new drugs?

Accepted Answer

Proof of efficacy in addition to safety

Answer

Child-resistant packaging

Answer

Black box warnings for dangerous drugs

Answer

Prescription-only status for habit-forming drugs