PTCB - Pharmacy Laws Exam Study Guide Solutions
Pure food and drugs act of 1906 - ANSWER-prohibit the interstate transportation or sale of
adulterated or misbranded food or drugs
What does Adulterated mean? - ANSWER-Consists of any filthy, decomposed, putrid susbtance
Perpared, packed, or help ...
Products that are dangerous to health under the labeled dosage
No ingredient/alcohol content if have alcohol
Failed to bear the established name of the drug
Durham-Humphrey Act of 1951 - ANSWER✔✔-Amendment of FDCA 1938
Require all products to have adequate directions for use
Don't need to have adequate directions for use if the drug/products must be dispense with a
prescription (not over-the-counter)
Separated drugs into Legend and Nonlegend (over the counter)
Allows verbal prescriptions over the phone
Allows refills to be called in from a doctors' office
Food, Drugs, and Cosmetic Act of 1938 (FDCA) - ANSWER✔✔-Created the US Food and Drug
Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding
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