Pharmacy Law

Question 1

Laws are categorized by

Answer 1

Criminal, civil, administrative

Question 2

Statutes are laws that are….

Answer 2

Passed by congress and signed by the president

Question 3

Laws are categorized by…

Answer 3

Criminal, civil, administrative

Question 4

Criminal laws are…

Answer 4

Homicide, illegal drugs, thefts, and antisocial behavior.

Question 5

Civil law-

Answer 5

Personal injury, business disputes, land details, libel and slander, commercial interests and non criminal matter

Question 6

Plaintiff

Answer 6

The one taking to court

Question 7

Defendant

Answer 7

The one being accused

Question 8

Tort law

Answer 8

Often civil but can overlap into criminal

Question 9

Medical malpractice falls under which law?

Answer 9

Tort law, most often named civil lawsuit brought on by plaintiff

Question 10

What is the main purpose of the CDC

Answer 10

Protect public health and safety

Question 11

NIOSH - national institute of occupational safety and health works under who?

Answer 11

CDC

Question 12

CMS- formerly known as the health care financing administration regulates what programs

Answer 12

Medicare, Medicaid, state children’s health insurance program, health insurance probability and accountability act (hippa) clinical laboratory improvements

Question 13

DEA regulates legal trade of..

Answer 13

Narcotic and dangerous drugs

Question 14

DEA works directly with….

Answer 14

FBI

Question 15

FDA does what?

Answer 15

Protect public health ensuring safety, efficiency and security of drugs

Question 16

FDA reviews and approves what?

Answer 16

New drug application, new generic equivalents, new therapeutic indications for existing meds.

Question 17

Pure Food and Drug act of 1906

Answer 17

Law that made it possible for federal inspection of meat products and forbade sale, manufacture and transport of altered food products and poisonous medicines

Question 18

Shirley Amendment of 1912

Answer 18

It prohibited the use of fraudulent therapeutic claims by drug companies.

Question 19

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

Answer 19

It required manufacturers to provide package inserts and to follow FDA guidelines to present evidence of safety for new drugs before marketing. This law also gives the FDA authority to issue food standards and inspect facilities

Question 20

Durham-Humphrey Amendment of 1951

Answer 20

Created a distinction between “OTC” and “Legend Drugs”.

Question 21

Durham-Humphrey Amendment of 1951 also known as

Answer 21

Prescription Drug Amendmet

Question 22

Federal Hazardous Substances Act 1960

Answer 22

FDA began labeling harmful substances including corrosive, toxic, flammable, pressure generating

Question 23

Kefauver-Harris Amendment of 1962

Answer 23

Also known as the “Drug Efficacy Amendment”.

• Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .

Question 24

Comprehensive Drug Abuse Prevention and Control Act of 1970 also known as

Answer 24

Controlled substance act 1970

Question 25

Comprehensive Drug Abuse Prevention and Control Act of 1970

Answer 25

Created a closed system for controlled substances monitored by DEA and started the scheduling system

Question 26

Poison Prevention Packaging Act of 1970

Answer 26

(PPPA) all legend and controlled drugs, with some exceptions, must be dispensed in a childproof container.

Question 27

Occupational Safety and Health Administration (OSHA) 1970

Answer 27

Regulates workplace environment; makes sure that businesses provide workers with safe and healthful working conditions

Question 28

Drug Listing Act of 1972

Answer 28

Requiring manufacturers, repackages, distributors to register the product and list all commercial drug products with FDA

Question 29

Medical Device Amendment of 1976

Answer 29

Requires life-sustaining and life-supporting devices to have premarket approval from the FDA

Question 30

Orphan Drug Act of 1983

Answer 30

Provided incentives for the development of orphan drugs for treatment of rare diseases

Question 31

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 31

simplified the process for generic drugs to be approved

Question 32

Drug Price Competition and Patent Term Restoration Act of 1984 also known as

Answer 32

Hatch-Waxman act

Question 33

Anabolic Steroid Control Act of 1990

Answer 33

Made anabolic steroids a schedule 3

Question 34

Prescription Drug Marketing Act of 1987

Answer 34

Addressed the "gray" area of marketing miss labeled, subpotent, adulterer, expired or counterfeit medications

Question 35

Omnibus Budget Reconciliation Act of 1990also known as

Answer 35

OBRA

Question 36

Omnibus Budget Reconciliation Act of 1990

Answer 36

Mandated drug utilization reviews similar to MTM and counseling

Question 37

Dietary Supplement Health and Education Act of 1994

Answer 37

This act changed the definition and regulations for dietary supplements

Question 38

Health Insurance Portability and Accountability Act 1996

Answer 38

Ensures confidentiality of patients medical records set guidelines for maintaining the privacy of health

Question 39

Health Insurance Portability and Accountability act 1996 also known as

Answer 39

HIPAA

Question 40

FDA Modernization Act of 1997

Answer 40

Simplified the rules and made it easier and quicker for FDA to approve new drugs or grant access into investigated medications

Question 41

Drug addiction treatment act of 2000

Answer 41

DEA registered and approved physicians allowed to proscribe controls as a means to detox or maintain individuals with opioid addiction

Question 42

Medicare Modernization Act of 2003

Answer 42

Offered voluntary benefits of Medicare advantage or Medicare part D for prescription coverage

Question 43

USP Chapter 797 - 2004

Answer 43

Enforced standards for sterile compounding

Question 44

Combat Methamphetamine Epidemic Act of 2005

Answer 44

Enacted to regulate the OTC sales of pseudoephedrine.

Question 45

The Medicaid Tamper-Resistant Prescription Pad Law of 2008

Answer 45

required that all written prescriptions for covered outpatient drugs are required to be written on a tamper-resistant prescription pad.

Question 46

Affordable Care Act of 2010

Answer 46

Made an open market for people to shop for incurace