Chapter 2 Pharmacy Laws and Regulations

Which of the following best defines the terms laws, regulations, standards, and professional ethics?

• Laws are rules enforced by governments, regulations are detailed directives, standards are agreed-upon guidelines, and professional ethics are moral principles guiding behavior.

• Laws are only suggestions, regulations are personal opinions, standards are random, and professional ethics are not important.

• Laws and regulations are the same, standards are not used, and professional ethics are illegal.

• Laws are company policies, regulations are unwritten rules, standards are not documented, and professional ethics are optional.

Summarize how drug injuries and deaths lead to protective legislation. Describe significant federal drug laws in the 20th century and their effects on pharmacy practice in the United States.

• Drug injuries and deaths prompted protective legislation, leading to significant federal drug laws in the 20th century that shaped pharmacy practice in the U.S.

• Drug injuries and deaths had no impact on legislation or pharmacy practice in the U.S.

• Federal drug laws in the 20th century were unrelated to drug injuries and deaths and did not affect pharmacy practice.

• Protective legislation in the U.S. was established before any drug injuries or deaths occurred, with no effect on pharmacy practice.

The different roles of government regulatory agencies and professional organizations—such as the Food and Drug Administration, Drug Enforcement Administration, and US Pharmacopeial Convention—include:

• Creating standards and enforcing laws and regulations

• Manufacturing and distributing pharmaceuticals

• Providing direct patient care in hospitals

• Developing marketing strategies for drug companies

History of Drug Regulation in the United States: In the 19th century, was opium liberally used in many medications?

• Yes

• No

History of Drug Regulation in the United States: In the 19th century, were there regulations protecting consumers from unscientific medicine claims?

• Yes

• No

In the 19th century, there was _______ regulation of medications in the United States.

• no

• strict

• comprehensive

• federal

What did the advertisement claim the product could cure?

• Rheumatism

• Headaches

• Toothaches

• All of the above

Which federal agency is responsible for the regulation of food and drugs in the United States?

• Drug Enforcement Administration (DEA)

• Food and Drug Administration (FDA)

• Occupational Safety and Health Administration (OSHA)

• Federal Trade Commission (FTC)

Fill in the blank: The DEA stands for _________.

• Drug Enforcement Administration

• Department of Environmental Affairs

• Drug Evaluation Agency

• Defense Enforcement Agency

Which agency is responsible for occupational safety and health regulations?

• Food and Drug Administration (FDA)

• Drug Enforcement Administration (DEA)

• Occupational Safety and Health Administration (OSHA)

• Centers for Disease Control and Prevention (CDC)