Home > Preview
The flashcards below were created by user
on FreezingBlue Flashcards.
- require that labels not contain false info of a drug's strength and purity.
- first Federal law regulating drugs
- Prevented the manufacture, sale or distribution of innacurately labeled food and drugs across state lines
PURE FOOD AND DRUG ACT (1906)
- Called for the creation of the FDA
- Required all drug manufactures to file a new drug application (NDA) to provide evidence of a drug's safety before any frug could be approved for the market.
FOOD, DRUG, AND COSMETIC ACT (1938)
- this amendment to the Food, Drug, and Cosmetic Act established clear criteria for the classification of prescription or nonprescription OTC meds
- Also authorized the taking of verbal prescriptions and the refilling of prescriptions
DURHAM-HUMPHREY AMENDMENT (1951)
- This amendment required that all medications be pure, safe and effective for use in humans
- Also required all drug manufacturers to file an investigation new drug application (INDA) before starting a clinical trial to humans
KEFAUVER-HARRIS AMENDMENT (1963)
- Also known as the controlled substance act
- required the pharmaceutical industry to keep records and implement measures for certain medications to prevent and controll drug abuse
- divided controlled substances into 5 schedules, or classes based on their potential for abuse
COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT (1970)
- Established standards for Child-resistant packaging
- required that some OTC meds and almost all legend drugs be packaged in child resistant containers
POISON PREVENTION PACKAGING ACT (1970)
Assigns a unique drug code to each medication as the NAtional Drug Code (NDC)
DRUG LISTING ACT (1972)
- also known as the Drug Price Competition and Patent-Term Restoration Act
-Ensured that brand-name drug manufacturers would have patent protection
- also created a generic drug-approval process and established .......
WAXMAN-HATCH ACT (1984)
-Focused on reforming the regulation of food, medical products and cosmetics
- Changed labeling requirements of all legend drugs from "Caution: Federal Law..... " to "RX only"
FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT (1997)
- requires that pharmacies that fill prescriptions for Medicaid, obtain, record and maintain basic patient information
- Also says that each state must require pharmacists to offer counseling on all aspects of drug therapy to patients
OMNIBUS BUDGET RECONCILIATION ACT (OBRA) (1990)
What would you like to do?
Home > Flashcards > Print Preview