Laws

Question 1

The Pure Food and Drug Act of 1906

Answer 1

• Law that provided for federal inspection of meat products and forbade the manufacture, sale, or transport of adulterated food products or poisonous patent medications (granted the federal government authority to ban unsafe drugs, prohibit manufactures from making false statements about their drugs, and required labeling to identify contents of products)
• This law does not cover cosmetics

Question 2

The Food, Drug, and Cosmetic Act of 1938

Answer 2

• Goal to limit interstate commerce in drugs to those that are safe and effective
• Manufacturers are required to submit evidence that new drugs are safe and effective
• All drugs had warnings and directions for use
• New drugs required clinical testing before marketed to public
• ## Drugs for cosmetics, diagnostic agents, and therapeutic devices were regulated for the first time

Question 3

Prescription Drug Act

Answer 3

= The Durham-Humphrey Amendment of 1951

Question 4

The Durham-Humphrey Amendment of 1951

Answer 4

Required prescription drugs bear the legend “Caution: federal law prohibits dispensing without a prescription
- Only reason why prescription drugs are considered legend drugs

Question 5

Drug Efficiency Act

Answer 5

The Kefauver-Harris Amendment of 1962

Question 6

The Kefauver-Harris Amendment of 1962

Answer 6

Focused on drug manufactures accountability for the efficacy (effectiveness) of the drugs (law came due to thalidomide disaster of 1962 due to a sedative which was for anti nausea for pregnant women)

• Required to have proof of the effectiveness before coming to market
• Advertising of the drug was placed under supervision of the FDA
• Procedures of new drug applications and investigation drugs were established

Question 7

Controlled Substance Act of 1970

Answer 7

The Comprehensive Drug Abuse and Prevention & Control Act of 1970

Question 8

The Comprehensive Drug Abuse and Prevention & Control Act of 1970

Answer 8

Combined all federal laws dealing with narcotics, stimulants, depressants and abused designer drugs

• Established the FDA
• Closed system for distribution with those registered with the FDA
• Established 5 classes

Question 9

What law established the FDA?

Answer 9

The Comprehensive Drug Abuse and Prevention & Control Act of 1970 = Controlled substance act of 1970

Question 10

The Poison Prevention Packaging Act of 1970

Answer 10

• All legend drugs and controlled substances must be dispensed in childproof containers (with some exceptions to the elderly with a written request)

Question 11

OSHA

Answer 11

The Occupational Safety and Health Act of 1970

Question 12

The Occupational Safety and Health Act of 1970

Answer 12

• Goal to ensure worker and workplace safety

- Also OSHA created the National Institute for Occupational Safety and Health

Question 13

The Drug Listing Act of 1972

Answer 13

• Required that all drug establishments register their products with the Food and Drug administration
• Gave each drug an NDC

Question 14

The Medical Device Amendment of 1976

Answer 14

• Required that the safety and effectiveness of life sustaining and life-supporting devices have pre-market approval by the FDA

Question 15

The Orphan Drug Act of 1983

Answer 15

• Congress passed to stimulate development of drugs for rare diseases that affect less than 200,000 people

Question 16

The Drug Price Competition and Patent Term Restoration Act of 1984

Answer 16

= Hatch-Waxman Act

Question 17

The Drug Price Competition and Patent Term Restoration Act of 1984

Answer 17

• Established the modern system of generic drugs
• Manufactures allowed them to file abbreviated new drug applications to seek FDA approval of generic versions for which drugs’s patents are expected to expire

Question 18

The Prescription Drug Marketing Act of 1987

Answer 18

• Addressed drug marketing practices that have contributed to the diversion of large quantities of drugs into a secondary “gray” market
• Allowed for free samples and drug coupons to occur and discounted drugs at hospitals

Question 19

The Anabolic Steroid Control Act of 1990

Answer 19

• Placed anabolic steroids as C3 medications

- They stimulate muscle growth

Question 20

The Omnibus Budget Reconciliation Act of 1990

Answer 20

= OBRA ‘90

Question 21

The Omnibus Budget Reconciliation Act of 1990

Answer 21

• Focused on federal funding of the medicare and medicaid programs
• created an increase need for techs
• and that pharmacists offer counseling when requested by patient

Question 22

The Dietary Supplement Health and Education Act of 1994

Answer 22

• Define dietary supplements and ingredients
• Framework for establishing safety
• Grants FDA to establish good manufacturing practice regulations

Question 23

The Health Insurance Portability and Accountability Act Of 1996

Answer 23

= HIPPA

Question 24

The Health Insurance Portability and Accountability Act Of 1996 (HIPPA)

Answer 24

Ensured patient confidentiality and privacy

Question 25

The Combat Methamphetamine Epidemic Act of 2005 (CMEA)

Answer 25

Began to regulate retail over the counter