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Pharmacy Calculations And Body System Theory > Pharmacy Law > Flashcards

Pharmacy Law Flashcards

1
Q

Laws are categorized by

A

Criminal, civil, administrative

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2
Q

Statutes are laws that are….

A

Passed by congress and signed by the president

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3
Q

Laws are categorized by…

A

Criminal, civil, administrative

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4
Q

Criminal laws are…

A

Homicide, illegal drugs, thefts, and antisocial behavior.

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5
Q

Civil law-

A

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

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6
Q

Plaintiff

A

The one taking to court

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7
Q

Defendant

A

The one being accused

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8
Q

Tort law

A

Often civil but can overlap into criminal

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9
Q

Medical malpractice falls under which law?

A

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

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10
Q

What is the main purpose of the CDC

A

Protect public health and safety

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11
Q

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

A

CDC

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12
Q

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

A

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

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13
Q

DEA regulates legal trade of..

A

Narcotic and dangerous drugs

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14
Q

DEA works directly with….

A

FBI

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15
Q

FDA does what?

A

Protect public health ensuring safety, efficiency and security of drugs

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16
Q

FDA reviews and approves what?

A

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

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17
Q

Pure Food and Drug act of 1906

A

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

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18
Q

Shirley Amendment of 1912

A

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

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19
Q

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

A

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

20
Q

Durham-Humphrey Amendment of 1951

A

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

21
Q

Durham-Humphrey Amendment of 1951 also known as

A

Prescription Drug Amendmet

22
Q

Federal Hazardous Substances Act 1960

A

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

23
Q

Kefauver-Harris Amendment of 1962

A

Also known as the “Drug Efficacy Amendment”.

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

24
Q

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

A

Controlled substance act 1970

25
Q

Comprehensive Drug Abuse Prevention and Control Act of 1970

A

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

26
Q

Poison Prevention Packaging Act of 1970

A

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

27
Q

Occupational Safety and Health Administration (OSHA) 1970

A

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

28
Q

Drug Listing Act of 1972

A

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

29
Q

Medical Device Amendment of 1976

A

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

30
Q

Orphan Drug Act of 1983

A

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

31
Q

Drug Price Competition and Patent Term Restoration Act of 1984

A

simplified the process for generic drugs to be approved

32
Q

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

A

Hatch-Waxman act

33
Q

Anabolic Steroid Control Act of 1990

A

Made anabolic steroids a schedule 3

34
Q

Prescription Drug Marketing Act of 1987

A

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

35
Q

Omnibus Budget Reconciliation Act of 1990also known as

A

OBRA

36
Q

Omnibus Budget Reconciliation Act of 1990

A

Mandated drug utilization reviews similar to MTM and counseling

37
Q

Dietary Supplement Health and Education Act of 1994

A

This act changed the definition and regulations for dietary supplements

38
Q

Health Insurance Portability and Accountability Act 1996

A

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

39
Q

Health Insurance Portability and Accountability act 1996 also known as

A

HIPAA

40
Q

FDA Modernization Act of 1997

A

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

41
Q

Drug addiction treatment act of 2000

A

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

42
Q

Medicare Modernization Act of 2003

A

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

43
Q

USP Chapter 797 - 2004

A

Enforced standards for sterile compounding

44
Q

Combat Methamphetamine Epidemic Act of 2005

A

Enacted to regulate the OTC sales of pseudoephedrine.

45
Q

The Medicaid Tamper-Resistant Prescription Pad Law of 2008

A

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

46
Q

Affordable Care Act of 2010

A

Made an open market for people to shop for incurace

Pharmacy Calculations And Body System Theory (8 decks)

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