QUESTIONS AND ANSWERS
2024/2025 UPDATED
Pure Food and Drug Act (1906)
Forbade the manufacture, sale, and transportation of adulterated or mislabeled foods
and drugs.
Shirley Amendment of 1912
Prevented fraudulent therapeutic claims by drug manufacturers
Harrison Act of 1914
Established the word narcotic and required the use of a stamp on narcotic drug
containers. Also regulated the importation, manufacture, sale, and use of opium,
codeine, and their derivatives
Food, Drug, and Cosmetic Act of 1938
A New drug could not be marketed until proven safe, tested for toxicity, and required
adverse drug effects to be reported.
Durham-Humphrey Amendment (1951)
Replaced Laws of 1938. Required designation of whether or not the drug was
prescription or OTC
Schedule I
This type of drug has no accepted medical use in the United States and has a high
potential for abuse
Schedule II drugs
Accepted for medical use but with severe restrictions (high potential for abuse)
Schedule III drugs
Have low potential for abuse with an accepted medical use. Perscription only
Schedule IV
Abuse potential exists, but less than Sch III. Examples are: Ambien, Darvocet and
Lorazepam.
Schedule V drugs
Lowest potential for abuse. May be sold OTC to people that show ID
Kefauver-Harris Amendment (1962)
Requires proof of safety and efficacy of a drug for approval before marketing
Controlled Substances Act (1970)
Replaced all laws passed prior to it concerning drug control. 5 drug schedules put in
place based on potential for abuse.
Poison Prevention Packaging Act (1970)
Implemented child resistant packaging
, Drug Listing Act of 1972
drugs must have a National Drug Code number.
Drug Regulation and Reform Act of 1978
Quicker development and distribution of new drugs
Orphan Drug Act of 1983
Established funding for research of rare chronic illnesses for new and old drugs.
Drug Price Competition and Patent Term Restoration Act of 1984
Eased requirements for marketing generic drugs
Omnibus Budget Reconciliation Act (OBRA 1990)
Mandated that OTC drugs be documented
Anabolic Steroid Control Act of 1990
placed all into category III drugs (CSA)
Prescription Drug Amendments of 1992
Allowed rapid approval of drugs for life-threatening diseases
Food and Drug Administration Modernization Act of 1997
Allowed rapid approval of drugs by the FDA
Pharmacokinesis
the movement of drugs through the body via absorbtion, distribution, metabolism, and
excretion
drug blood level
amount of a drug present in the blood
plasma binding
when proteins bind to drugs and decrease the amount of free-flowing drug in the
bloodstream allowing the drug to stay in the body for longer.
Examples of Sulfonamides
Sulfamethoxazole, sulfisoxazole, sulfadiazine
Uses for Sulfonamides
Treating UTIs, Ulcerative colitis, 2nd and 3rd degree burns
Drugs that interact with Sulfonamides
Oral anticoagulants, methotrexate, and hydantoins
What are the 4 groups of penicillin?
Natural penicillins, penicillinase-resistant penicillins, aminopenicillins, extended-
spectrum penicillins
Uses for Penicillins
UTIs, Septicemia, Meningitis, Intra-Abdominal infections, Sexually Transmitted
Infections (syphilis), Pneumonia and other respiratory infections
What variables can effect drug dosage?
Weight, Age, Height, Gender, Genetics, Diet
Another name for antianxiety drugs
Anxiolytics
Benzodiazepines
category 4 meds
3 Examples of antianxiety drugs
alprazolam, doxepin, lorazepam
Acroynm for cancer in adults?
CAUTION