PTCB Pharmacy Laws
1. Pure food and drugs act of 1906
Answer: prohibit the interstate transportation or saleof adulterated or misbranded food or
drugs
2. What does Adulterated mean?
Answer:
Consists of any filthy, decomposed, putrid substance
Perpared, packed, or help under unsanitary conditions
Perpared in containers composed of any poisonous or deleterious substance
Containing unsafe color additives
Recognized in an official compendium but differing in strength, quality, or purity ofthe drugs
3. What does Misbranding mean?
Answer:
False labeling
No label
Label lacks Name, place of business of the manufacturer/packer/distributor, lackaccurate
quantity of contents.
No Warning if the product is habit forming
No labeled direction for use and no warning against certain pathological conditions
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
4. Durham-Humphrey Act of 1951
Answer:
Amendment of FDCA 1938Require all products to have adequate directions for use
Don't need to have adequate directionsfor use ifthe drug/products must be dispensewith 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
5. Food, Drugs, and Cosmetic Act of 1938 (FDCA)
Answer:
Created the US Food andDrug Administration (FDA)
Required all new drug applications be filed with the FDA
Clearly defined Adulteration and misbranding
6. Kefauver-Harris Amendment of 1962
Answer: Requires all medication in the US to bepure, safe, and effective