Reading 1 & 2 - Definitions Flashcards
What is the 4 part definition of a drug?
- approved by official compendium
- intented to treat, prevent, or cure a disease in man or animal
- intenteded to affect the body of man or animal by chemical action
- intended for use as a component of any article specified
What is included as “official compendium”?
United States Pharmacopeia - National Formulary (USP-NF)
Homeopathic Pharmacopeia of the United States (HPUS)
What is the definition of prescription drug?
Drug intented for man which because of harmful effects is not safe unless under supervision of a licensed practitioner OR limited by an approved application under section 355 (new drug)
The definition of over the counter drug?
Drug safe and effective for use without a prescriber’s supervision for certain conditions
Which of the following are included as dietary supplements:
- Amino acids
- Herbs
- Tobacco
- Vitamins
All but TOBACCO!!!!!!
What is GRAS and GRAE?
Generally Recognized as Safe
Generally Recognized as Effective
What application is needed to get approval by the FDA after clinical trials?
New Drug Application
What application is needed to be reviewed by FDA before conducting clinical trials on a drug?
Investigation New Drug Application (IND)
The definition of orphan drug
drugs used for a condition affecting less than 200,000 people in the US, OR there is no reasonable cost benefit when it affects more than 200,000 people
Definition of Estabilished Name
Generic Name of a drug products
What is responsible for the established name of a drug?
United States Adopted Names (USAN)
Label vs Labeling
Label is what is printed on the actual product
Labeling is anything added to the container or included with the product
What is the PPPA?
Poison Prevention Packaging Act
Requires special packaging on drug products to inhibit children under 5 from opening products within a reseasonable amount of time
What is a DESI drug?
Drugs marketed between 1938 - 1962 that has been deemed SAFE, but needed to prove their efficacy
What is the application to FDA to show proof of bioequivalence?
Abbreviated New Drug Application
Out of the 3 drug applications (NDA, IND, ANDA), which one do you not need to prove safety and efficacy?
ANDA
What drugs never had official clinical trials but have been deemed safe and effective due to their time on the market?
Pre-‘38 Drugs / Grandfathered Drugs
EX: Digoxin
What do two Pharmaceutical Equivalent drugs have in common? What can they differ in?
Dosage Form
Active Ingredient
Strength
Differing in look, release mechanism, expiration, labeling
What is the definition of Therapeutic Equivalent?
Two Pharmacetical Equivalent drugs that have the same clinical safety profile
What is the definition of “state”?
All 50 US state plus any territory of the US
EX: Puerto Rico, Guam, District of Columbia, Republic of Marshall Islands
What are the 3 required components of a device?
-Recognized by USP-NF
- Intented for use in diagnosis, cure, or prevention of a disease in man or animals
- They afffect the structure of body NOT through chemical action (no metaboliam, they stay intact)
***there is no such thing as “homeopathic devices”
Definition of Biological Product:
“a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, allergenic, protein, arsphenamine, or analogous product used to prevent, treat, or cure a disease for human beings”
NOT for animals…
What is USC? Used for rules or statutes?
United States Code
Laws or Statues coming from a body of elected officials
What is CFR? Used for rules or statutes?
Code of Federal Regulations
Regulations issued by an administrative agency
What is the IC?
Indiana Code
Laws established by a body of electived officials
The Indiana BoP develops laws or regulations?
Regulations === they are NOT elected officials
Laws or Rules that need to go through public commenting before finalized?
Rules and Regulations!!!
What organizations develop rules and regulations?
FDA
DEA
Indiana BoP
T or F: A new drug that requires regular lab tests to monitor for adverse events at normal doses
would likely be approved as an over-the-counter-drug.
FALSE
T or F: Although used in animals, prescription drugs are only approved for use in humans.
