PTCB Pharmacy Laws
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PTCB Pharmacy Laws
- 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 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 of the drugs
- What does Misbranding mean?
Answer:
False labeling No label Label lacks Name, place of business of the manufacturer/packer/distributor, lack accurate 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
- 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
- Kefauver-Harris Amendment of 1962
Answer: Requires all medication in the US to be pure, safe, and effective
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