Laws
Laws
Organizations
Organizations
Types of Oversight
100

Food and drugs could no longer be adulterated or misbranded

What is the Pure Food and Drug Act?

100

Created to prevent accidental childhood drug poisonings

What is the Poison Prevention PAckaging Act?

100

Enforces the Controlled Substance Act

Who is the DEA?

100

Prevents unfair competition?

Who is the Federal Trade Commission?


100

Rules that arer passed by the legislative branches of government

What are laws?

200

Established legend and patent drugs

What is the Durham Humphrey-Amendment?

200

Established NDC numbers

What is the Drug Listing Act?

200

Approves new drugs to be sold in the United States

Who is the FDA?

200

Sets standards of verification of product quality

What is USP?

200

Legislated rules and procedures that exist to carry out the law

What are regulations?

300

Act responsible for creating the FDA

What is the Food, Drug, and Cosmetic Act?

300

Provided grants and tax incentives to manufacturers who made drugs for rare conditions

What is the Orphan Drug Act?

300

Verifies internet pharmacy practice sites (VIPPS)

Who is National Association of Boards of Pharmacy (NABP)?

300

Regulates the requirements for becoming a pharmacy technician

Who is the State Board of Pharmacy?

300

Benchmarks or desired normal levels of quality for products or professionals

What are standards?

400

Required and IND application and proof of safety and efficacy

What is the Kefauver-Harris Amendment?

400

Created streamlined process for approving generic drugs

What is the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)?

400

Sets health and safety standards for American workplaces

Who is the Occupational Safety and Health Administration (OSHA)?

400

Supports pharmacy practice in health-system pharmacies

Who is the American Society of Health-System Pharmacists (ASHP)?

400

This organization sets standards for compounding sterile and nonsterile compounds

What is USP?

500

Created to combat and control drug abuse

What is the Comprehensive Drug Abuse Prevention and Control Act (Control Substance Act)?

500

Required DURs and MTMs

What is the Omnibus Budget Reconciliation Act (OBRA-90)?

500

Controls pandemics and epidemics

What is the Centers for Disease Control and Prevention?

500

Supports and focuses on pharmacy practice in community pharmacies

What is the American Pharmacists Association?

500

Following a code of high professional standards using moral principles

What is ethics?

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