Medical Laws

Question 1

Poison Prevention Act of 1970

Answer 1

• Required child resistant containers (with some exceptions)

Question 2

Orphan Drug Act Of 1983

Answer 2

• Encouraged companies to create orphan drugs

Question 3

Occupational Health and Safety Administration (OSHA)

Answer 3

• Regulates workplace safety

Question 4

FDA Modernization Act

Answer 4

• Changed labels from “legend” to Rx only

Question 5

Drug Price Competition and Patent-Term Resportation Act of 1984

Answer 5

• Simplified the process for generic drugs to be approved

- Extended patents for new drugs

Question 6

Comprehensive Drug Abuse Prevention and Control Act of 1970

Answer 6

• Classified drugs based on their potential for abuse

- Created the Drug Enforcement Administration (DEA)

Question 7

Dietary Supplement Health and Education Act (DSHEA) of 1994

Answer 7

• Defined dietary supplement

- Authorized the FDA to remove any unsafe dietary supplement from the market

Question 8

Durham-Humphrey Amendment of 1951

Answer 8

• Distinction made under U.S. federal law between drugs that can and cannot be purchased from a physician without a prescription
• Separated over-the-counter from prescription drugs
• No directions on prescription drugs
• Allowed limited refilling
• Allowed verbal orders

Question 9

Omnibus Budget Reconciliation Act of 1990 (OBRA-90)

Answer 9

States required pharmacists to offer to COUNSELING to patients and complete a Drug Use Review

Question 10

Kefauver-Harris Amendment on 1962

Answer 10

• Required that drugs must be effective

- Required manufacturers to file an Investigational New Drug Application

Question 11

Prescription Drug Marketing Act of 1987

Answer 11

• Specifies which agents could legally be drugs

Question 12

Drug Act of 1972

Answer 12

• Each new drug MUST have a National Drug Code Number (NDC) - universal product identifier or human drugs, assigned by the FDA
• 10 digits, 3 segments that give the (1) manufacturer code, (2) product/drug and dosage, (3) package size

Question 13

Pure Food and Drug Act of 1906

Answer 13

• Prohibited the interstate sale and transmission of harmful or mislabeled drugs

Question 14

Health Insurance Portability and Accountability Act of (HIPPA) 1996

Answer 14

• Set up rules to protect patient privacy

- HIPPA violations are reported to the USA Department of Health and Inspector General (OIG), and/or to the provider

Question 15

Food, Drug and Cosmetic Act (FDCA) of 1938

Answer 15

• Required manufacturers to file a new drug application
• Required manufacturers to prove new drugs were safe to use
• Defined harmful drugs
• Defined mislabeling of drugs
• Authorized the FDA to carry out inspections