B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 3 — Questions and Answers
Question 1: Which federal law first required proof of drug safety before FDA approval?
- Pure Food and Drug Act of 1906
- Food, Drug, and Cosmetic Act of 1938 (Correct answer)
- Kefauver-Harris Amendment of 1962
- Drug Price Competition Act of 1984
Correct 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.
Question 2: Which amendment to the FD&C Act required manufacturers to prove both safety AND efficacy?
- Durham-Humphrey Amendment
- Kefauver-Harris Amendment (Correct answer)
- Hatch-Waxman Amendment
- Orphan Drug Act
Correct 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.
Question 3: The Orange Book published by the FDA is used to identify:
- Controlled substance schedules
- Drug-drug interactions
- Therapeutic equivalence of approved drug products (Correct answer)
- State pharmacy board regulations
Correct 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.
Question 4: A pharmacist who refuses to fill a valid controlled substance prescription without cause may be violating which principle?
- Principle of beneficence only
- The patient's right to access medically necessary medications (Correct answer)
- DEA registration requirements
- The pharmacy's formulary policy
Correct 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.
Question 5: Which of the following is a requirement for a valid Schedule III-V prescription under federal law?
- Must be written on security paper
- Must include the prescriber's DEA number (Correct answer)
- Cannot be telephoned in
- Must be filled within 24 hours
Correct 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.
Question 6: Under the Omnibus Budget Reconciliation Act (OBRA) of 1990, pharmacists are required to offer counseling to:
- All patients regardless of payer
- Only Medicaid outpatients (Correct answer)
- Only patients receiving new prescriptions
- Only patients over age 65
Correct 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.
Question 7: Which law established the National Drug Code (NDC) system?
- Drug Listing Act of 1972 (Correct answer)
- Controlled Substances Act of 1970
- Food, Drug, and Cosmetic Act of 1938
- Drug Price Competition and Patent Term Restoration Act of 1984
Correct 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.
B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 3
Which federal law first required proof of drug safety before FDA approval?