Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence Flashcards
7 cards from real B.Pharm. Bachelor of Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence flashcards as text
Which federal law first required proof of drug safety before FDA approval?
Answer: Food, Drug, and Cosmetic Act of 1938
The Food, Drug, and Cosmetic Act of 1938 required manufacturers to prove drug safety before marketing, prompted by the sulfanilamide disaster.
Which amendment to the FD&C Act required manufacturers to prove both safety AND efficacy?
Answer: Kefauver-Harris Amendment
The Kefauver-Harris Amendment of 1962 added the requirement that drugs must be proven effective in addition to safe before FDA approval.
The Orange Book published by the FDA is used to identify:
Answer: Therapeutic equivalence of approved drug products
The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on safety and effectiveness and their therapeutic equivalence ratings.
A pharmacist who refuses to fill a valid controlled substance prescription without cause may be violating which principle?
Answer: The patient's right to access medically necessary medications
Refusing to fill a valid prescription without legitimate cause may violate the patient's right to access medically necessary medications and may constitute professional misconduct.
Which of the following is a requirement for a valid Schedule III-V prescription under federal law?
Answer: Must include the prescriber's DEA number
Federal law requires that prescriptions for Schedule III-V controlled substances include the prescriber's DEA registration number.
Under the Omnibus Budget Reconciliation Act (OBRA) of 1990, pharmacists are required to offer counseling to:
Answer: Only Medicaid outpatients
OBRA '90 mandated prospective drug utilization review and patient counseling offers for Medicaid outpatients specifically, though many states extended this to all patients.
Which law established the National Drug Code (NDC) system?
Answer: Drug Listing Act of 1972
The Drug Listing Act of 1972 required drug manufacturers to register with the FDA and established the National Drug Code system to identify drug products.