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Pharmacy Law Practice Exam Questions
Pharmacy Law Practice Exam Questions 
Which FDCA amendment exempted certain drugs from the "adequate directions for use" labeling 
requirement if they bear "Rx only" on their labels? 
a. Durham Humphrey 
b. Kefauver-Harris 
c. Prescription Drug Marketing 
d. Waxman-Hatch a. Durham Humphrey 
The FDCA defines a "new drug" as a previously approved drug entity with a new: 
a. route of administration. 
b. indication for use. 
c. combination of ingredients. 
d. a and b 
e. a, b and c...