Pharmacy Law and Regulations Flashcards
7 cards from real PTCE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Pharmacy Law and Regulations flashcards as text
Which of the following best describes the role of the State Board of Pharmacy?
Answer: Licenses pharmacists and regulates pharmacy practice within the state
State Boards of Pharmacy license pharmacists and pharmacy technicians and regulate the practice of pharmacy within their respective states.
Under the DSCSA (Drug Supply Chain Security Act), pharmacies must be able to trace a recalled drug product back through how many prior transactions?
Answer: The entire supply chain back to the manufacturer
The DSCSA requires full track-and-trace capability across the entire pharmaceutical supply chain from manufacturer to dispenser.
A prescription for alprazolam (Schedule IV) is presented 4 months after it was written. The technician should:
Answer: Refuse — it has exceeded the 6-month validity period
Schedule III and IV prescriptions expire 6 months from the date written; this prescription is outside that window and cannot be filled.
Which of the following is an example of a medication error category under the NCC MERP index classified as 'Category E'?
Answer: Error contributed to temporary harm requiring intervention
NCC MERP Category E describes an error that reached the patient, caused temporary harm, and required intervention (e.g., additional treatment).
Which law established the Risk Evaluation and Mitigation Strategies (REMS) program?
Answer: Food and Drug Administration Amendments Act (FDAAA) of 2007
The FDAAA of 2007 gave the FDA authority to require REMS programs for drugs with serious safety risks to ensure benefits outweigh risks.
A pharmacy technician may accept a new oral prescription order ONLY if:
Answer: The prescriber calls directly and the pharmacist is present to take it over immediately
In most states, technicians cannot independently accept new verbal prescription orders; a pharmacist must be immediately available to receive and verify the order.
The Kefauver-Harris Amendment of 1962 added which requirement for new drugs?
Answer: Proof of efficacy in addition to safety
Prompted by the thalidomide tragedy, the Kefauver-Harris Amendment required manufacturers to prove both safety AND efficacy before FDA approval.