Federal Laws Flashcards Preview

Pharm Tech > Federal Laws > Flashcards

Flashcards in Federal Laws Deck (17)
Loading flashcards...
1
Q
  • 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
A

Pure Food and Drug Act of 1906

2
Q
  • Clearly defined adulteration and misbranding.
  • Created the federal agency called the Food and Drug Administration.
  • Required that products be safe for human use.
A

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

3
Q
  • 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.
A

Durham-Humphrey Amendments to FDCA of 1951

4
Q
  • 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.
A

Kefauver-Harris Amendment to FDCA of 1962

5
Q
  • Established the federal agency called the Drug Enforcement Agency (DEA).
  • Classified drugs that have the potential for abuse and/or addiction into five classes.
A

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

6
Q

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

A

Drug Listing Act of 1972

7
Q
  • 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.
A

Orphan Drug Act of 1983

8
Q
  • Streamlined the FDA approval process for marketing generic drugs.
  • Extended the term of patents for companies that develop new drugs.
A

Drug Price Competition and Patent Term Restoration Act of 1984

9
Q

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

A

Prescription Drug Marketing Act of 1987

10
Q

-Redefined anabolic steroids as Schedule III controlled substances.

A

Anabolic Steroid Control Act of 1990

11
Q
  • Required pharmacist to engage in drug utilization reviews (DUR).
  • Required pharmacists to offer counseling to patients about their prescriptions without charge.
A

Omnibus Budget Reconciliation Act (OBRA) of 1990

12
Q
  • 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.
A

Dietary Supplement Health and Education Act (DSHEA) of 1994

13
Q
  • Addressed patient privacy concerns.

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

A

Health Insurance Portability and Accountability Act (HIPAA) of 1996

14
Q
  • Provided a voluntary prescription drug plan for Medicare patients for additional cost.
  • Created a type of health insurance called health savings accounts
A

Medicare Modernization Act of 2003

15
Q
  • Changed federal legend to “Rx Only”

- Legalized compounding

A

FDA Modernization Act of 2004

16
Q

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

A

Combat Methamphetamine Epidemic Act of 2005

17
Q

-Mandate health insurance

A

Patient Protection and Affordable Care Act of 2010