Pharmacy Law and Regulations Flashcards
6 cards from real ExCPT Test practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Pharmacy Law and Regulations flashcards as text
Under HIPAA, which of the following is considered Protected Health Information (PHI)?
Answer: A patient's diagnosis combined with their name and date of birth
PHI is individually identifiable health information that includes any data element (name, date, condition, etc.) that could be used to identify a specific person's health status.
The Drug Supply Chain Security Act (DSCSA) requires pharmacies to track which of the following?
Answer: The chain of custody (transaction history) for prescription drug products
DSCSA (2013) establishes an electronic, interoperable system to track and trace prescription drugs through the supply chain to prevent counterfeit, stolen, or harmful products.
Under federal law, how long must a pharmacy retain records for Schedule II controlled substances?
Answer: 2 years
Federal DEA regulations require pharmacies to maintain Schedule II records for a minimum of 2 years; however, many states require longer retention periods.
A prescriber writes for amoxicillin 500 mg capsules, but the pharmacy has amoxicillin 500 mg tablets in stock. What should the pharmacy technician do?
Answer: Check with the pharmacist before making any substitution
Even minor substitutions require pharmacist authorization. The pharmacist must review therapeutic equivalence and any clinical implications before approving a formulation change.
Which law established the framework for the FDA's authority over prescription vs. over-the-counter drug classification?
Answer: Durham-Humphrey Amendment of 1951
The Durham-Humphrey Amendment of 1951 defined which medications require a prescription (legend drugs) vs. those that can be sold OTC, and established the legal framework for pharmacist dispensing.
A pharmacy is notified of a Class I drug recall. What should happen IMMEDIATELY?
Answer: Remove the affected product from shelves and quarantine it
A Class I recall indicates the highest risk — reasonable probability that use will cause serious adverse health consequences or death. Immediate removal and quarantine is required.