UPDATE 2026
Chemical Name - Answers Chemical constitution of a drug
Generic Name - Answers -Before a drug becomes official it is given a generic name
or COMMON NAME
-NOT CAPITALIZED
Brand Name - Answers -Followed by a symbol which indicates that the name is
registered by manufacturer
Which name is usually listed by the FDA and used by the NCLEX? - Answers
Generic Name
Which name is easier to pronounce and capitalized? - Answers Brand Name
Pharmacology - Answers Study of drugs and their actions or effects
Greek Meaning of Pharmacology - Answers Drugs and Science
Drugs - Answers Chemical substances that have an effect on living organisms
Therapeutic Drugs - Answers Used for prevention or treatment of disease
Diet therapy - Answers Treatment with diet
Drug therapy - Answers Treatment with drugs/medications
Physiotherapy - Answers Treatment with natural forces
Psycotherapy - Answers Treatment to limit stress
Body System Classification - Answers Groups drugs based on the organ system they
affect (cardiovascular, gastrointestinal, etc)
Therapeutic use/Clinical indications - Answers Grouping drugs by the condition they
treat (antacids and antibiotics)
Physiologic/chemical action - Answers How the drug works at a cellular or chemical
level/what class they are in (calcium channel blockers, anticholinergics)
Prescription Drugs - Answers Require an order by a health professional licensed to
prescribe drugs
Nonprescription Drugs - Answers Over the Counter (OTC) drugs sold without a
prescription
Illegal/Recreational Drugs - Answers Used for nontherapeutic purposes; obtained
illegally
Official source for American drug standards - Answers -The United States
Pharmacopeia (USP)/National Formulary (NF)
-USP Dictionary of USAN and International Drug Names
What are sources for prescription and nonprescription Drugs? - Answers -Package
Inserts
-Nursing journals
-Electronic databases
Which source for Drugs is the most up to date? - Answers Electronic databases
What is the Federal Food, Drug, and Cosmetic Act (1938, 1952, 1962)? - Answers A
law ensuring the safety of drugs and cosmetics before they are marketed and released
to the public.
What is the primary focus of the Controlled Substances Act (1970)? - Answers To
improve the administration and regulation of drugs that require control by the
government because of their high incidence of abuse.
What defines a Schedule I (C-I) drug? - Answers Highest abuse potential and NOT
ACCEPTED MEDICAL USE (Heroin, LSD, Ecstasy, Marijuana)
, What defines a Schedule II (C-II) drug? - Answers High abuse potential but HAS
ACCEPTED MEDICAL USES (Morphine, Oxycodone, Methamphetamine)
What defines a Schedule III (C-III) drug? - Answers Less abuse potential than C-II
with accepted medical uses (Hydrocodone, Anabolic Steroids)
What defines a Schedule IV (C-IV) drug? - Answers Lowest Class; Less abuse
potential than C-III with accepted medical uses (Xanax, Valium, Ambien)
What defines a Schedule V (C-V) drug? - Answers Lowest abuse potential of the
schedules with accepted medical uses (Cough medicine with Codeine)
Who must register with the DEA? - Answers Manufacturers, prescribers, and
dispensers handling controlled substances
How are hospital drug inventories tracked? - Answers Through strict dispersion
records, Pyxis systems, and physical counts.
Possession of controlled substances for individuals without a prescription - Answers
Federal and state law make it a crime punishable by fine, imprisonment, or both and
possible loss of professional licensing
Durham Humphrey Amendment 1952 - Answers Divides meds into prescription and
non-prescription based on safety. Requires caution label that federal law prohibits
dispensing without script
Drug Development - Answers Takes 8-15 Years and more than 2 billion dollars in
research and development to bring a new drug to market
Food, Drug, and Cosmetic Act of 1938 - Answers Requires FDA to determine the
safety of drugs before marketing
4 stages of FDA rules and regulations for drugs development - Answers 1. Preclinical
research and development
2. Clinical research and development
3. New drug application review
4. Post marketing surveillance
Preclinical Research begins with - Answers Discovery, synthesis, and purification of
a drug.
What is the main goal of Preclinical Research? - Answers To use lab studies to
determine if experimental drug has a therapeutic value and if it is safe in animals
What does IND stand for in drug development? - Answers Investigational new drug
IND application (Preclinical research) - Answers -Sent to FDA and they have 30 days
to determine safety to allow human studies
-Only 20% of chemical tested make it to next phase
Clinical Research - Answers Human are first tested
What is studied during Phase 1 Clinical Research? - Answers Drugs pharmacologic
properties (pharmacokinetics, metabolism, safe dosage ranges, routes)
Who is typically chosen as the population group for Phase 1 Clinical Research? -
Answers Normal volunteers (do not need tx) and those who need treatment
How long does Phase 1 Clinical Research usually last? - Answers About 4-6 Weeks
What population group is tested during Phase 2 Clinical Research? - Answers A
smaller population of patients WHO ACTUALLY HAVE THE CONDITION the
drug treats
What is the focus of Phase 3 Clinical Research - Answers A larger patient population
to gather info on proper dosage and safety
Who reviews each completed study during Clinical Research? - Answers FDA
What is the purpose of Fast Tracking a Parallel Tracking? - Answers To make INDs
available to patients with life-threatening illnesses