Federal Pharmacy Law A/B

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1

Pure Food and Drug Act of 1906

-Prohibited foods and drugs distributed through interstate commerce from being adulterated or misbranded

-did not require manufactures to list ingredients or directions for use

-did not regulate cosmetics or medical devices

2

Pure Food and Drug Act of 1906

Did not require manufactures to list ingredients or directions for use

3

Pure Food and Drug Act of 1906

Did not regulate cosmetics or medical devices

4

Food, Drug and Cosmetic Act of 1938

- Any new drug had to be proven safe when used according to label directions

-label had to include adequate directions for use and habit-forming warnings

- first law that applied to food, drugs, cosmetics, and devices

-drugs marketed prior to 1938 were exempt from regulation

5

Food, Drug and Cosmetic Act of 1938

-any new drug had to be proven safe when used according to label directions

6

Food, Drug and Cosmetic Act of 1938

labels had to include: adequate directions for use and habit forming warnings

7

Food, Drug and Cosmetic Act of 1938

first law to apply to cosmetics and medical devices

8

Food, Drug and Cosmetic Act of 1938

drugs marketed prior to 1938 were exempt from regulation

9

Durham-Humphrey Amendment of 1951

-Established 2 classifications of drugs

-Prescription or legend drugs: drug that requires medical supervision for safe use; did not require "adequate directions for use" on the label from the manufacturer; adequate directions for use is when the pharmacist places the directions on the label; required "caution: federal law prohibits dispensing without a prescription"

- non prescription drugs or over the counter

-do not require medical supervision

-required adequate direction for use on the label

- provided for oral prescriptions and refills

10

Durham-Humphrey Amendment of 1951

-Established 2 classifications of drugs

11

Durham-Humphrey Amendment of 1951

-Prescription or legend drugs: drug that requires medical supervision for safe use; did not require "adequate directions for use" on the label from the manufacturer; adequate directions for use is when the pharmacist places the directions on the label; required "caution: federal law prohibits dispensing without a prescription"

12

Durham-Humphrey Amendment of 1951

- non prescription drugs or over the counter

-do not require medical supervision

-required adequate direction for use on the label

13

Durham-Humphrey Amendment of 1951

- provided for oral prescriptions and refills

14

Kefauver-Harris Amendment of 1962

- drug efficacy amendment

-required all drugs marketed in the US be safe and effective extended to products between 1938-1962

-Created Good Manufacturing Practice (GMP)

- Prescription drug advertising is the FDA (Food and Drug Administration)

-Nonprescription drugs advertising is the FTC (Federal Trade Commission)

-Required informed consent for research subject in clinical investigations

15

Kefauver-Harris Amendment of 1962

- drug efficacy amendment

16

Kefauver-Harris Amendment of 1962

-required all drugs marketed in the US be safe and effective extended to products between 1938-1962

17

Kefauver-Harris Amendment of 1962

-Created Good Manufacturing Practice (GMP)

18

Kefauver-Harris Amendment of 1962

- Prescription drug advertising is the FDA (Food and Drug Administration)

19

Kefauver-Harris Amendment of 1962

-Nonprescription drugs advertising is the FTC (Federal Trade Commission)

20

Kefauver-Harris Amendment of 1962

-Required informed consent for research subject in clinical investigations

21

Comprehensive Drug Abuse Prevention and Control Act of 1970

- AKA Controlled Substance Act (CSA)

- Created 5 Schedules for controlled substances

-est. explicit record keeping and inventory requirements

-significant penalties for violating the CSA

22

Comprehensive Drug Abuse Prevention and Control Act of 1970

- AKA Controlled Substance Act (CSA)

23

Comprehensive Drug Abuse Prevention and Control Act of 1970

- Created 5 Schedules for controlled substances

24

Comprehensive Drug Abuse Prevention and Control Act of 1970

-est. explicit record keeping and inventory requirements

25

Comprehensive Drug Abuse Prevention and Control Act of 1970

-significant penalties for violating the CSA

26

Poison Prevention Packaging Act of 1970

-failure to comply with packaging requirements is considered misbranding

-legend drugs and controlled substances must be in child resistant containers: exceptions are sublingual NTG, anhydrous cholestyramine, oral contraceptives and pancrelipase

-OTC must be sold in child resistant packaging: except manufactors may market one size of an OTC product for the elderly/ handicapped but must say "this package for households without young children"

27

Poison Prevention Packaging Act of 1970

-failure to comply with packaging requirements is considered misbranding

28

Poison Prevention Packaging Act of 1970

-legend drugs and controlled substances must be in child resistant containers: exceptions are sublingual NTG, anhydrous cholestyramine, oral contraceptives and pancrelipase

29

Poison Prevention Packaging Act of 1970

-OTC must be sold in child resistant packaging: except manufactors may market one size of an OTC product for the elderly/ handicapped but must say "this package for households without young children"

30

Medical Device Amendment of 1976

-amendment that provided for better classification of medical devices according to their specific function

-establish performance standards and pre-marktet approval of medical devices

-medical devices must be manufactured with GMP (good manufacturing practices)

-outlined record keeping and reporting requirements for medical devices

31

Medical Device Amendment of 1976

-amendment that provided for better classification of medical devices according to their specific function

32

Medical Device Amendment of 1976

-establish performance standards and pre-marktet approval of medical devices

33

Medical Device Amendment of 1976

-medical devices must be manufactured with GMP (good manufacturing practices)

34

Medical Device Amendment of 1976

-outlined record keeping and reporting requirements for medical devices

35

Orphan Drug Act of 1983

- provided tax and licensing incentives to manufacturers in exchange for developing "orphan drugs"

-orphan drugs are used to treat rare diseases affect 1 in 200,000 people

36

Orphan Drug Act of 1983

- provided tax and licensing incentives to manufacturers in exchange for developing "orphan drugs"

37

Orphan Drug Act of 1983

-orphan drugs are used to treat rare diseases affect 1 in 200,000 people

38

Hatch-Waxman Amendment of 1984

- streamlined the drug approval process for generic products by requiring only an abbreviated new drug application (ANDA)

-AKA Drug Price Competition and Patent-Term Restoration Act

-must prove bioequlvalence between generic and brand name counterpart

39

Hatch-Waxman Amendment of 1984

- streamlined the drug approval process for generic products by requiring only an abbreviated new drug application (ANDA)

40

Hatch-Waxman Amendment of 1984

-AKA Drug Price Competition and Patent-Term Restoration Act

41

Hatch-Waxman Amendment of 1984

-must prove bioequlvalence between generic and brand name counterpart

42

Prescription Drug Marketing Act of 1987

- placed more stringent controls on the distribution of prescriptions and samples by:

1. requiring licensing of prescription drug wholesalers

2. banned re-importation of prescription drugs produced in the US

3. banned the sale, trade or purchase of drug samples

4. specified storage, handling and record keeping requirements for drug samples

5. prohibited resale of prescription drugs purchased by hospitals or health care facilities

43

Prescription Drug Marketing Act of 1987

- requiring licensing of prescription drug wholesalers

44

Prescription Drug Marketing Act of 1987

- banned re-importation of prescription drugs produced in the US

45

Prescription Drug Marketing Act of 1987

- banned the sale, trade or purchase of drug samples

46

Prescription Drug Marketing Act of 1987

- specified storage, handling and record keeping requirements for drug samples

47

Prescription Drug Marketing Act of 1987

- prohibited resale of prescription drugs purchased by hospitals or health care facilities

48

Omnibus Reconciliation Act of 1990

-outlined expectations of the pharmacist with regards with patient interaction

-primary goal was to save the federal government money by improving therapeutic outcomes:

1.pharmacist counseling obligations

2.prospective drug utilization review requirements

3.record keeping mandates

49

Omnibus Reconciliation Act of 1990

-outlined expectations of the pharmacist with regards with patient interaction

50

Omnibus Reconciliation Act of 1990

-primary goal was to save the federal government money by improving therapeutic outcomes:

1.pharmacist counseling obligations

2.prospective drug utilization review requirements

3.record keeping mandates

51

Health Insurance Portability and Accountability Act of 1996

-privacy rule component took place on April 14, 2003

-regulations designed to safeguard privacy of protected health info (PHI)

-imposed 5 key provisions

1. Pharmacies must take reasonable step to limit use, disclosure, and the request of PHI

2. Individuals must be informed of the privacy practices of the pharmacies

3. a compliance officer within the pharmacy must be identified and manage and ensure compliance

4. all employees must receive HIPAA training

5. when PHI disclosure is required it is disclosed to a second party for the purposes only engaged by the pharmacy

52

Health Insurance Portability and Accountability Act of 1996

-privacy rule component took place on April 14, 2003

53

Health Insurance Portability and Accountability Act of 1996

-regulations designed to safeguard privacy of protected health info (PHI)

54

Health Insurance Portability and Accountability Act of 1996

-imposed 5 key provisions

1. Pharmacies must take reasonable step to limit use, disclosure, and the request of PHI

2. Individuals must be informed of the privacy practices of the pharmacies

3. a compliance officer within the pharmacy must be identified and manage and ensure compliance

4. all employees must receive HIPAA training

5. when PHI disclosure is required it is disclosed to a second party for the purposes only engaged by the pharmacy

55

FDA Modernization Act of 1997

-provided fast track review of some NDA's with the intent to expedite approval of drugs used to treat serious or life threatening conditions

-clarification under extemporaneously compound prescriptions

-replaced prescription drug legend with "RX Only"

-removed the "warning-may be habit forming" labeling requirement

-encouraged manufacturers to conduct research for new uses for currently approved drugs

-encouraged manufacturers to perform pediatric drug studies

56

FDA Modernization Act of 1997

-provided fast track review of some NDA's with the intent to expedite approval of drugs used to treat serious or life threatening conditions

57

FDA Modernization Act of 1997

-clarification under extemporaneously compound prescriptions

58

FDA Modernization Act of 1997

-replaced prescription drug legend with "RX Only"

59

FDA Modernization Act of 1997

-removed the "warning-may be habit forming" labeling requirement

60

FDA Modernization Act of 1997

-encouraged manufacturers to conduct research for new uses for currently approved drugs

61

FDA Modernization Act of 1997

-encouraged manufacturers to perform pediatric drug studies

62

Medicare Prescription Drug Improvement and Modernization Act of 2003

- AKA Medicare Modernization Act (MMA)

- encompasses four programs A, B, C, and D

-established formal medication therapy management programs

63

Medicare Prescription Drug Improvement and Modernization Act of 2003

- AKA Medicare Modernization Act (MMA)

64

Medicare Prescription Drug Improvement and Modernization Act of 2003

- encompasses four programs A, B, C, and D

65

Medicare Prescription Drug Improvement and Modernization Act of 2003

-established formal medication therapy management programs

66

Combat Methamphetamine Epidemic Act of 2005

-part of the patriot act

-regulates retail over the counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products:

1. sales limits and record keeping

2. regulated product placement

3. set minimum age requirements for purchasers

4. required packaging for manufactures

5. self certification for sellers

67

Combat Methamphetamine Epidemic Act of 2005

-part of the patriot act

68

Combat Methamphetamine Epidemic Act of 2005

-regulates retail over the counter sales of ephedrine, pseudoephedrine, and phenylpropanolamine products:

1. sales limits and record keeping

2. regulated product placement

3. set minimum age requirements for purchasers

4. required packaging for manufactures

5. self certification for sellers

69

Medicaid Tamper-Resistant Prescription Law of 2007

-requires physicians and pharmacists to use either electronic prescriptions or tamper-resistant prescription pads for medicaid patients

70

Food and Drug Administration Amendments of 2007

-requires risk evaluation and mitigation strategies (REMS) on medications

-medication guides and communications plans

-restricted drug programs: Thalidomide, Buprenorphine, Clozapine, Isotretinoin

71

Food and Drug Administration Amendments of 2007

-requires risk evaluation and mitigation strategies (REMS) on medications

72

Food and Drug Administration Amendments of 2007

-medication guides and communications plans

73

Food and Drug Administration Amendments of 2007

-restricted drug programs: Thalidomide, Buprenorphine, Clozapine, Isotretinoin

74

Patient Protection and Affordable Care Act of 2010

-requires all individuals have health insurance

-requires standards for financial and administrative transactions

-timely and transparent claims using standard electronic transaction format

-stops agreements between manufacturers that limits or delays competition by generics

-phases out the catastrophic threshold "donut hole" for medicare part D

75

Patient Protection and Affordable Care Act of 2010

-requires all individuals have health insurance

76

Patient Protection and Affordable Care Act of 2010

-requires standards for financial and administrative transactions

77

Patient Protection and Affordable Care Act of 2010

-timely and transparent claims using standard electronic transaction format

78

Patient Protection and Affordable Care Act of 2010

-stops agreements between manufacturers that limits or delays competition by generics

79

Patient Protection and Affordable Care Act of 2010

-phases out the catastrophic threshold "donut hole" for medicare part D

80

Drug Quality and Security Act of 2013

-address issues related to oversight of prescription compounding and establishes standards for a national "track and trace" systems for drug distribution

-created voluntary registration for "outsourcing facilities"

-Outsourcing facilities are:

1. subject to certain requirements similar to those that currently govern traditional drug manufacturers

2. subject t inspection by the FDA

-est. a 10 year plan to electronically track each drug product unit from the manufacturer all the way to the patient

81

Drug Quality and Security Act of 2013

-address issues related to oversight of prescription compounding and establishes standards for a national "track and trace" systems for drug distribution

82

Drug Quality and Security Act of 2013

-created voluntary registration for "outsourcing facilities"

-Outsourcing facilities are:

1. subject to certain requirements similar to those that currently govern traditional drug manufacturers

2. subject t inspection by the FDA

83

Drug Quality and Security Act of 2013

-est. a 10 year plan to electronically track each drug product unit from the manufacturer all the way to the patient