Alabama Pharmacy Law Exam Prep: MPJE-Style
Questions, Answers, and Rationales
1. The Pure Food and Drug Act of 1906 is also known as:
A) The Durham-Humphrey Act
B) The Wiley Law
C) The Kefauver-Harris Amendment
D) The Controlled Substances Act
Answer: B) The Wiley Law
,*Rationale:* The Pure Food and Drug Act of 1906, commonly referred to as the Wiley Law, was the first federal law to prohibit adulteration
and misbranding of foods and drugs in interstate commerce .
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2. Which federal law established the distinction between prescription and over-the-counter drugs?
A) Food, Drug and Cosmetic Act of 1938
B) Durham-Humphrey Amendment of 1951
C) Kefauver-Harris Amendment of 1962
D) Hatch-Waxman Act of 1984
Answer: B) Durham-Humphrey Amendment of 1951
*Rationale:* The Durham-Humphrey Amendment established the prescription and OTC drug categories, allowed for oral prescriptions, and
permitted refills on prescriptions .
3. What did the Kefauver-Harris Amendment of 1962 require for new drugs?
A) Only safety testing
B) Only efficacy testing
C) Both safety AND efficacy testing
,D) Neither safety nor efficacy testing
Answer: C) Both safety AND efficacy testing
*Rationale:* The Kefauver-Harris Amendment required that new drugs be proven effective (not just safe), mandated informed consent, gave
the FDA authority to regulate prescription drug advertising, and established Good Manufacturing Practices (GMPs) .
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4. The Hatch-Waxman Act of 1984 primarily relates to:
A) Generic drug approval
B) Poison prevention packaging
C) Controlled substance scheduling
D) Pharmacy compounding standards
Answer: A) Generic drug approval
*Rationale:* The Hatch-Waxman Act allowed generics to submit Abbreviated New Drug Applications (ANDAs) requiring only bioequivalence
data, not full safety and efficacy trials. It also provided brand manufacturers with 5 additional years of patent protection .
, ---
5. Which federal agency regulates over-the-counter drug advertising?
A) FDA
B) FTC
C) DEA
D) EPA
Answer: B) FTC
*Rationale:* While the FDA regulates prescription drug advertising, the Federal Trade Commission (FTC) has jurisdiction over OTC drug
advertising .
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Alabama Board of Pharmacy Structure
6. How many members serve on the Alabama State Board of Pharmacy?
A) 3 members
Questions, Answers, and Rationales
1. The Pure Food and Drug Act of 1906 is also known as:
A) The Durham-Humphrey Act
B) The Wiley Law
C) The Kefauver-Harris Amendment
D) The Controlled Substances Act
Answer: B) The Wiley Law
,*Rationale:* The Pure Food and Drug Act of 1906, commonly referred to as the Wiley Law, was the first federal law to prohibit adulteration
and misbranding of foods and drugs in interstate commerce .
---
2. Which federal law established the distinction between prescription and over-the-counter drugs?
A) Food, Drug and Cosmetic Act of 1938
B) Durham-Humphrey Amendment of 1951
C) Kefauver-Harris Amendment of 1962
D) Hatch-Waxman Act of 1984
Answer: B) Durham-Humphrey Amendment of 1951
*Rationale:* The Durham-Humphrey Amendment established the prescription and OTC drug categories, allowed for oral prescriptions, and
permitted refills on prescriptions .
3. What did the Kefauver-Harris Amendment of 1962 require for new drugs?
A) Only safety testing
B) Only efficacy testing
C) Both safety AND efficacy testing
,D) Neither safety nor efficacy testing
Answer: C) Both safety AND efficacy testing
*Rationale:* The Kefauver-Harris Amendment required that new drugs be proven effective (not just safe), mandated informed consent, gave
the FDA authority to regulate prescription drug advertising, and established Good Manufacturing Practices (GMPs) .
---
4. The Hatch-Waxman Act of 1984 primarily relates to:
A) Generic drug approval
B) Poison prevention packaging
C) Controlled substance scheduling
D) Pharmacy compounding standards
Answer: A) Generic drug approval
*Rationale:* The Hatch-Waxman Act allowed generics to submit Abbreviated New Drug Applications (ANDAs) requiring only bioequivalence
data, not full safety and efficacy trials. It also provided brand manufacturers with 5 additional years of patent protection .
, ---
5. Which federal agency regulates over-the-counter drug advertising?
A) FDA
B) FTC
C) DEA
D) EPA
Answer: B) FTC
*Rationale:* While the FDA regulates prescription drug advertising, the Federal Trade Commission (FTC) has jurisdiction over OTC drug
advertising .
---
Alabama Board of Pharmacy Structure
6. How many members serve on the Alabama State Board of Pharmacy?
A) 3 members
