Federal Laws

Question 1

• First law to regulate the development, compounding, distribution, storage and dispensing of drugs.
• No false or misleading information on label about drug strength or purity.
• No interstate transport or sale

Answer 1

Pure Food and Drug Act of 1906

Question 2

• Clearly defined adulteration and misbranding.
• Created the federal agency called the Food and Drug Administration.
• Required that products be safe for human use.

Answer 2

Food, Drug, and Cosmetic Act (FDCA) of 1938

Question 3

• Distinguished between prescription (legend) and nonprescription drugs.
• Required that all drug products have adequate usage directions or bear the legend “Caution: Federal Law Prohibits without Prescription.”
• Allowed verbal prescription and refill requests by telephone.

Answer 3

Durham-Humphrey Amendments to FDCA of 1951

Question 4

• Required that drugs be not only safe but effective as well.
• Required that pharmaceutical manufacturers file and Investigation New Drug Application before starting clinical trials on humans.

Answer 4

Kefauver-Harris Amendment to FDCA of 1962

Question 5

• Established the federal agency called the Drug Enforcement Agency (DEA).
• Classified drugs that have the potential for abuse and/or addiction into five classes.

Answer 5

Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act) of 1970

Question 6

-Required National Drug Code numbers to be assigned to every marketed drug

Answer 6

Drug Listing Act of 1972

Question 7

• Provided tax incentives for developing and marketing drugs used to treat rare conditions (Orphan drugs).
• Established lifelong exclusive license to manufacturer that developed and orphan drug.

Answer 7

Orphan Drug Act of 1983

Question 8

• Streamlined the FDA approval process for marketing generic drugs.
• Extended the term of patents for companies that develop new drugs.

Answer 8

Drug Price Competition and Patent Term Restoration Act of 1984

Question 9

-Prohibited the re-importation of drugs to the United States, except by the manufacturer.

Answer 9

Prescription Drug Marketing Act of 1987

Question 10

-Redefined anabolic steroids as Schedule III controlled substances.

Answer 10

Anabolic Steroid Control Act of 1990

Question 11

• Required pharmacist to engage in drug utilization reviews (DUR).
• Required pharmacists to offer counseling to patients about their prescriptions without charge.

Answer 11

Omnibus Budget Reconciliation Act (OBRA) of 1990

Question 12

• Treated herbal supplements as food products, rather than drugs.
• Prohibited manufacturers of herbs and dietary supplements from making claims that their products treat or cure any specific diseases or illness.

Answer 12

Dietary Supplement Health and Education Act (DSHEA) of 1994

Question 13

• Addressed patient privacy concerns.

- Allowed for employees to more easily move their health insurance from one job to another.

Answer 13

Health Insurance Portability and Accountability Act (HIPAA) of 1996

Question 14

• Provided a voluntary prescription drug plan for Medicare patients for additional cost.
• Created a type of health insurance called health savings accounts

Answer 14

Medicare Modernization Act of 2003

Question 15

• Changed federal legend to “Rx Only”

- Legalized compounding

Answer 15

FDA Modernization Act of 2004

Question 16

-Restricted sales of OTC drugs used in the manufacture of methamphetamines, such as pseudoephedrine, ephedrine, and phenylpropanolamine.

Answer 16

Combat Methamphetamine Epidemic Act of 2005

Question 17

-Mandate health insurance

Answer 17

Patient Protection and Affordable Care Act of 2010