Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
25 Cards in this Set
- Front
- Back
|
Pure Food and Drug Act of 1906
|
prohibited foods and drugs that were distributed through interstate commerce to be adulterated or misbranded
did not have to list ingredients did not have to have directions for use did not regulate cosmetic products or medical devices |
|
|
Food, Drug, and Cosmetic Act of 1938
|
result of diethylene glycol in sulfanilamide elixir
must be proven safe when used according to directions on the label required directions on label and warnings first law that appllied to cosmetic products and medical devices |
|
|
Durham-Humphrey Amendment of 1951
|
two classes of drugs established:
1. Legend (must include "caution: Federal law prohibits dispensing without a prescription") 2. over-the-counter also provided for oral prescriptions and prescription refills |
|
|
Kefauver-Harris Amendment of 1962
|
result of thalidomide
-drugs must be safe -FDA controls rx advertising -informed consent required for research -adverse drug reactions must be reported -creation of Good Manufacturing Practice (GMP) |
|
|
Who controls prescription drug advertising?
Who controls non-prescription drug advertising? |
rx- FDA
OTC- Federal Trade Commission (FTC) |
|
|
Orphan Drug Act of 1983
|
provided tax and licensing incentives to manufacturers who develop drugs for rare diseases (less then 200,000 people)
|
|
|
Drug Price Competition and Patent-Term Restoration Act
aka Waxman-Hatch Amendment |
Congress streamlined the drug approval process for generic products and provided innovative drug manufacturers with incentives to develop new drug products
|
|
|
Prescription Drug Marketing Act of 1987
|
- wholesalers must be licensed
-no re-importation -no sale, trade, or purchase of samples -storage, handling, and recordkeeping requirements for samples -no resale of prescription drugs purchased by hospitals |
|
|
FDA Modernization Act of 1997
|
-fast track review of drugs for serious or life-threatening conditions
-states should regulate compounding -pharmacies exempt from GMP -Caution: federal law prohibits dispensing without a prescription is replaced with Rx only -encouragement to find new uses of drugs by submitting NDA -pediatric studies get additional six months of marketing exclusivity |
|
|
Medicare Prescription Drug Improvement and Modernization Act of 2003
|
Part A- hospital
Part B- physician services Part C- manage care option Part D- prescription drugs premium- $420 deductible- $250 Catastrophic threshold- $5,100 per year can only change plans once a year between Nov 15-Dec 31 unless he/she moves enrollment: 3 mo before- 4 mo after birthday |
|
|
How to bring a new drug to the market?
|
IND Application- must be submitted to FDA before drug is administered to a human
Phase 1- small group of healthy individuals; assess safety, kinetics, and other properties Phase 2- 100 or more patients that have the disease or symptom; assess effectiveness, dosing, adverse effects Phase 3- Large group of patients (thousands); doulbe-blind NDA Phase 4- post-marketing surveillance |
|
|
What is a Treatment Investigational New Drug?
|
patient must be in an imminent life-threatening stage of an illness for which there is presently no cure
must be in either phase 2 or 3 |
|
|
Fast Track Product
|
granted for treatment of a serious or life-threatening condition and addresses an unmet medical need
|
|
|
Abbreviated New Drug Application (ANDA)
|
inroducing a drug under a preexisting generic name or as a brand name product
requires proof of similar kinetics, bioavailability, and clinical activity to that of the innovator's drug product |
|
|
Supplemental New Drug Application (SNDA)
|
application for making changes to an existing drug by changing synthesis, production procedures, manufacturing locations, packaging, labeling, etc.
new dosage form tablet strength new therapeutic use |
|
|
Therapeutic Classifications
Type P vs Type S |
Type P- major therapeutic gain because there are no other effective drugs available for treating a particular illness (priority)
Type S- drug is similar to other drugs on market (standard) |
|
|
Chemical Classification
Type 1 Type 2 Type 3 Type 4 Type 5 Type 6 |
Type 1- new molecular structure
Type 2- new derivative Type 3- new formulation of already marketed drug Type 4- new combo of 2 or more drugs Type 5- manufactured by new company Type 6- new therapeutic indication |
|
|
Type AA
Type E Type F Type N Type V |
Type AA- potential use for AIDS or HIV
Type E- drug for life-threatening or severely debilitating disease Type F- drug that has been placed on hold Type N- drug is being considered for non-prescription status Type V- drug is being considered for orphan drug status |
|
|
Orphan Drug
|
Drug for treatment of rare diseases or conditions (fewer than 200,000 persons in U.S.)
|
|
|
Who is responsible for designating a nonproprietary or generic name for a new drug?
Who must grant final approval for any drug? |
United States Adopted Names Council (USAN)
Secretary of Human Health Services (HHS) |
|
|
NDC
|
(manufacturer)-(ID of specific drug)- (ID of package)
NOT mandatory to put NDC number on package labeling |
|
|
Adulteration
vs Misbranding |
Adulteration- refers to composition
Misbranding- refers to labeling |
|
|
label
vs labeling |
label- text on immediate container
labeling- information on label, packaging, or inserts *flavoring and perfumes do not have to be included on labeling |
|
|
Special Label Warning Requirements
|
FD&C Yellow No. 5
Aspartame Sulfites Mineral Oil Wintergreen oil Sodium Phosphates Isoproterenol Inhalation products Ipecac Syrup Acetophenetidin (Phenacetin) Salicylates Alcohol Warning |
|
|
Pregnancy Warnings
|
Category A- no risk to fetus
Category B- no studies on pregnant women, but animal studies show no risk Category C- has not been determined Category D- positive evidence of risk to fetus Category X- risk clearly outweights any possible benefit |
