ExCPT Test Pharmacy Law and Regulations 3

Question 1

Under HIPAA, which of the following is considered Protected Health Information (PHI)?

Accepted Answer

A patient's diagnosis combined with their name and date of birth

Answer

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.

Question 2

The Drug Supply Chain Security Act (DSCSA) requires pharmacies to track which of the following?

Accepted Answer

The chain of custody (transaction history) for prescription drug products

Answer

DSCSA (2013) establishes an electronic, interoperable system to track and trace prescription drugs through the supply chain to prevent counterfeit, stolen, or harmful products.

Question 3

Under federal law, how long must a pharmacy retain records for Schedule II controlled substances?

Accepted Answer

2 years

Answer

Federal DEA regulations require pharmacies to maintain Schedule II records for a minimum of 2 years; however, many states require longer retention periods.

Question 4

A prescriber writes for amoxicillin 500 mg capsules, but the pharmacy has amoxicillin 500 mg tablets in stock. What should the pharmacy technician do?

Accepted Answer

Check with the pharmacist before making any substitution

Answer

Even minor substitutions require pharmacist authorization. The pharmacist must review therapeutic equivalence and any clinical implications before approving a formulation change.

Question 5

Which law established the framework for the FDA's authority over prescription vs. over-the-counter drug classification?

Accepted Answer

Durham-Humphrey Amendment of 1951

Answer

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.

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ExCPT Test Pharmacy Law and Regulations 3