FEDERAL LAW REVIEW NAPLEX QUESTIONS WITH COMPLETE SOLUTIONS

this act established a record keeping requirement for the receipt and dispensing of opium or coca leaf products.....the possession of narcotics without a prescription became illegal correct answer: 1914: harrison narcotic act the sulfanilamide disaster lead to this act's passage correct answer: Federal Food, drug, and cosemtic act of 1938 who is responsible for enforcing the FD&C act correct answer: FDA define prescription drugs "legend drugs" to distinguish between OTC drugs correct answer: durham-humphrey amendment 1951 triggered by the thalidomide disaster, increased scrutiny on safety, and the first to require evidence of effectiveness before marketing correct answer: kefauver-harris amendment 1962 nonprescription (OTC) advertising is regulated by who? correct answer: FTC - federal trade commission Rx drug advertising is regulated by who correct answer: FDA what are the three classes of the medical device amendment (1976) correct answer: class I - least regulation (needles, scissors etc) class II - must meet performance standards (insulin syringes, electric heating pads, thermometers) Class III - must have premarket approval bc they are life supporting (pacemaker, heart valves , etc) extended the ANDA to generics, thereby making generic approvals easier as well as extended patent life for brand drugs correct answer: The drug price competition and patent term restoration act of 1984 how long is the life of a patent correct answer: 20 years from the date of first filing the patent application