B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 3

Question 1

Which federal law first required proof of drug safety before FDA approval?

Accepted Answer

Food, Drug, and Cosmetic Act of 1938

Answer

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?

Accepted Answer

Kefauver-Harris Amendment

Answer

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:

Accepted Answer

Therapeutic equivalence of approved drug products

Answer

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?

Accepted Answer

The patient's right to access medically necessary medications

Answer

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?

Accepted Answer

Must include the prescriber's DEA number

Answer

Federal law requires that prescriptions for Schedule III-V controlled substances include the prescriber's DEA registration number.

B.Pharm. Bachelor of Pharmacy Practice Test

B.Pharm. Bachelor of Pharmacy Practice Test

B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 3