FPGEE Pharmacy Law and Ethics Flashcards

The Durham-Humphrey Amendment of 1951 established which important distinction in pharmacy practice?

Answer: Distinction between prescription-only (Rx) and over-the-counter (OTC) drugs

The Durham-Humphrey Amendment defined which drugs require a prescription and established the legal framework for Rx-only versus OTC classification.

A pharmacy technician calls in a refill authorization for a Schedule II controlled substance from a prescriber's office. Under federal law, this practice is:

Answer: Prohibited; Schedule II drugs cannot be refilled

Federal law prohibits refills of Schedule II controlled substances; a new prescription is required for each dispensing.

Under the Combat Methamphetamine Epidemic Act (CMEA), which requirement applies to the sale of pseudoephedrine-containing products?

Answer: Products must be kept behind the pharmacy counter and purchasers must show ID and sign a logbook

CMEA requires pseudoephedrine products to be stored behind the counter, with purchasers presenting photo ID, signing a logbook, and subject to daily/monthly purchase limits.

The concept of 'standard of care' in pharmacy malpractice refers to:

Answer: The level of care a reasonably competent pharmacist would provide under similar circumstances

Standard of care is the benchmark of what a reasonably competent pharmacist with similar training would do in comparable circumstances, used to evaluate negligence.

The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requires pharmacists in Medicaid programs to offer:

Answer: Drug utilization review (DUR) and patient counseling

OBRA-90 mandated prospective drug utilization review and an offer to counsel Medicaid patients about their medications.

Under the Kefauver-Harris Amendment of 1962, drug manufacturers must demonstrate to the FDA that new drugs are:

Answer: Safe and effective

The Kefauver-Harris Amendment, passed after the thalidomide tragedy, required manufacturers to prove both safety and efficacy before FDA approval.