Regulatory Acts in the U.S. Healthcare System

What was the primary purpose of the Food, Drug, and Cosmetic Act of 1938?

• To ban the use of certain chemicals in cosmetics

• To create new food safety standards

• To establish the FDA's authority over food, drugs, and cosmetics

• To regulate the advertising of food products

What did the Durham-Humphrey Amendment of 1951 establish?

• A new category of over-the-counter drugs

• The requirement for drug manufacturers to prove drug efficacy

• Two categories of drugs: prescription and over-the-counter

• A new system for drug approval

What was the main focus of the Kefauver-Harris Amendment of 1962?

• To regulate the marketing of cosmetics

• To establish new food labeling requirements

• To improve drug safety and efficacy

• To create a new drug approval process

What did the Comprehensive Drug Abuse Prevention and Control Act of 1970 require?

• The use of child-resistant packaging

• New safety standards for medical devices

• The creation of the FDA

• Strict record-keeping for certain drugs

What was the purpose of the Poison Prevention Packaging Act of 1970?

• To ban hazardous materials in households

• To require child-resistant packaging for certain products

• To establish new safety standards for cosmetics

• To regulate the sale of over-the-counter drugs

What was the main goal of the Occupational Safety and Health Act (OSHA) of 1970?

• To create new food safety standards

• To establish new drug approval processes

• To ensure safe working conditions

• To regulate the pharmaceutical industry

What did the Prescription Drug Marketing Act of 1987 aim to ensure?

• The regulation of drug advertising

• The safety and effectiveness of drug products

• The creation of new drug categories

• The establishment of new drug approval processes

What was the focus of the Omnibus Budget Reconciliation Act of 1987?

• To protect patient rights in long-term care facilities

• To create new food labeling requirements

• To establish new drug safety standards

• To regulate the marketing of prescription drugs

What did the Anabolic Steroids Control Act of 1990 regulate?

• The sale of over-the-counter drugs

• The safety of medical devices

• The use of anabolic steroids

• The marketing of prescription drugs

What was the purpose of the FDA Safe Medical Devices Act of 1990?

• To improve post-market surveillance of medical devices

• To create new safety standards for cosmetics

• To regulate the sale of prescription drugs

• To establish new drug approval processes