2026 EXAM Q AND A STUDY GUIDE
COMPLETE QUESTIONS AND ANSWERS
●● Shirley Amendment of 1912.
Answer: Prevented fraudulent therapeutic claims by drug manufacturers
●● Harrison Act of 1914.
Answer: Established the word narcotic and required the use of a stamp
on narcotic drug containers. Also regulated the importation,
manufacture, sale, and use of opium, codeine, and their derivatives
●● Food, Drug, and Cosmetic Act of 1938.
Answer: A New drug could not be marketed until proven safe, tested for
toxicity, and required adverse drug effects to be reported.
●● Durham-Humphrey Amendment (1951).
Answer: Replaced Laws of 1938. Required designation of whether or
not the drug was prescription or OTC
●● Schedule I.
Answer: This type of drug has no accepted medical use in the United
States and has a high potential for abuse
,●● Schedule II drugs.
Answer: Accepted for medical use but with severe restrictions (high
potential for abuse)
●● Schedule III drugs.
Answer: Have low potential for abuse with an accepted medical use.
Perscription only
●● Schedule IV.
Answer: Abuse potential exists, but less than Sch III. Examples are:
Ambien, Darvocet and Lorazepam.
●● Schedule V drugs.
Answer: Lowest potential for abuse. May be sold OTC to people that
show ID
●● Kefauver-Harris Amendment (1962).
Answer: Requires proof of safety and efficacy of a drug for approval
before marketing
●● Controlled Substances Act (1970).
Answer: Replaced all laws passed prior to it concerning drug control. 5
drug schedules put in place based on potential for abuse.
, ●● Poison Prevention Packaging Act (1970).
Answer: Implemented child resistant packaging
●● Drug Listing Act of 1972.
Answer: drugs must have a National Drug Code number.
●● Drug Regulation and Reform Act of 1978.
Answer: Quicker development and distribution of new drugs
●● Orphan Drug Act of 1983.
Answer: Established funding for research of rare chronic illnesses for
new and old drugs.
●● Drug Price Competition and Patent Term Restoration Act of 1984.
Answer: Eased requirements for marketing generic drugs
●● Omnibus Budget Reconciliation Act (OBRA 1990).
Answer: Mandated that OTC drugs be documented
●● Anabolic Steroid Control Act of 1990.
Answer: placed all into category III drugs (CSA)