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

State Boards of Pharmacy license pharmacists and pharmacy technicians and regulate the practice of pharmacy within their respective states.

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

The DSCSA requires full track-and-trace capability across the entire pharmaceutical supply chain from manufacturer to dispenser.

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

Schedule III and IV prescriptions expire 6 months from the date written; this prescription is outside that window and cannot be filled.

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

NCC MERP Category E describes an error that reached the patient, caused temporary harm, and required intervention (e.g., additional treatment).

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

The FDAAA of 2007 gave the FDA authority to require REMS programs for drugs with serious safety risks to ensure benefits outweigh risks.

(PTCE) Pharmacy Technician Certification Exam Practice Test