Laws
Food and drugs could no longer be adulterated or misbranded
What is the Pure Food and Drug Act?
Created to prevent accidental childhood drug poisonings
What is the Poison Prevention Packaging Act?
Enforces the Controlled Substance Act
Who is the DEA?
Prevents unfair competition
Who is the FTC?
Rules that are passed by the legislative banches of government.
What are laws?
Act responsible for creating the FDA
What is the Food, Drug, and Cosmetic Act?
Established NDC numbers
What is the Drug Listing Act?
Approves new drugs to be sold in the US
Who is the FDA?
Sets standards of verification of product quality
Who is USP?
Legislated rules and procedres that exist to carry out the law
What are regulations?
Established legend and patent drugs
What is the Durham-Humphrey Amendment?
Provided grants and tax incentives to manufacturers who made drugs for rare conditions
What is the Orphan Drug Act?
Verifies internet pharmacy practice sites (VIPPS)
Who is the NABP?
Regulates the requirements of pharmacy technicians
Who is state Boards of Pharmacy?
Benchmarks or desired normal levels of quality for products or professionals
What are standards?
Required IND application and proof of safety and efficacy
What is the Kefauver-Harris Amendment?
Created streamlined process for approving generic drugs
What is the Hatch-Waxman Act?
Sets health and safety standards for American workplaces
Who is OSHA?
Supports pharmacy practice in health-system pharmacies
Who is ASHP?
This organization sets standards for compounding sterile and non-sterile compounds
What is USP?
Created to combat and control drug abuse
What is the Controlled Substance Act?
Required DUR and MTM
What is OBRA 90?
Controls pandemics and epidemics
Who is the CDC?
Supports pharmacy practice in community pharmacies
Who is APhA?
Following a code of high professional standards using moral principles
What are ethics?