Pharmacy Law and Professional Standards

From the study guide

Course Outline

  1. Origins of Drug Regulation
  2. Pharmacy Oversight Organizations
  3. Four Types of Oversight
  4. Major Federal Pharmacy Laws
  5. USP Drug and Practice Standards
  6. Responsibilities of Pharmacy Personnel
  7. Courts and Pharmacy Lawsuits

1. Origins of Drug Regulation

Essential Points

  • In the 19th century, the United States had no effective drug regulation, opium was widely used in medications, and many medicines made scientifically unsupported claims.

  • Drug injuries and deaths contributed to the emergence of laws, regulatory agencies, and professional organizations during the 20th century to protect consumers and regulate medicines.

Memory Hook

Unregulated medicines → injuries and deaths → protective legislation

2. Pharmacy Oversight Organizations

Essential Points

  • Federal and state oversight bodies include:
    • Food and Drug Administration (FDA)
    • Drug Enforcement Administration (DEA)
    • Occupational Safety and Health Administration (OSHA)
    • Federal Trade Commission (FTC)
    • Centers for Disease Control and Prevention (CDC)
    • state boards of health and welfare agencies

3. Four Types of Oversight

Key Concepts & Definitions

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Practice quiz preview

1. Which condition characterized drug use and medicine claims in the United States during the nineteenth century?

2. What development did drug-related injuries and deaths help produce during the twentieth century?

3. Which group is part of the federal and state system for overseeing drugs and related health activities?

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Flashcard preview

What was the status of drug regulation in 19th century United States?

There was no effective drug regulation.

Which substance was widely used in 19th century medications in the US?

Opium was widely used.

What type of claims did many 19th century medicines make?

They made scientifically unsupported claims.

What contributed to the emergence of drug laws and agencies in the 20th century?

Drug injuries and deaths contributed to their emergence.

Which federal agency oversees drug safety and approval?

The Food and Drug Administration (FDA).

Which agency enforces controlled substances laws?

The Drug Enforcement Administration (DEA).

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Frequently asked questions

What does the Pharmacy Law and Professional Standards study guide cover?

It covers the core concepts of Pharmacy Law and Professional Standards, organized by topic with the key definitions, explanations and takeaways, so it's easier to learn and remember.

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The practice quiz has 21 multiple-choice questions, each with an explanation. Use it to check what you know and find your gaps.

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How do I study Pharmacy Law and Professional Standards with flashcards?

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