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Law > Federal Law Overview > Flashcards

Federal Law Overview Flashcards

1
Q

US Pharmacopeia (USP) founded

A

1820

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2
Q

creation of USP lead to

A

a system of quality control and a national formulary & standards; 11 members attended

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3
Q

first USP revision

A

1830; 7 members

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4
Q

USP revisions continue at what interval?

A

10 year

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5
Q

1848

A

drug import act- federal legislation recognizes the USP as an official compendium

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6
Q

1850

A

COPs invited to participate in USP revisions

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7
Q

State boards of pharmacy forms; USP becomes a state board requirment

A

1800-1890s

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8
Q

act passed following concern over unsanitary practices in food & drug industries

A

federal food & drug act of 1906

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9
Q

federal food & drug act of 1906 era was concerned with:

A

purity

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10
Q

1906 act was considered inadequate bc:

A
  • false statements made about a drug by a manufacturer were help by the courts not to be misbranding
  • did not extend to cosmetics
    did not grant authority to ban unsafe drugs
  • labels were not required to identify contents
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11
Q

the first attempts to control a specific drug class (narcotics)

A

international opium convention of 1912 & Harrison narcotic act of 1914

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12
Q

what made the import & export of narcotics a government supervised activity?

A

the second opium conference of 1925

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13
Q

created the FDA as we know it today

A

food, drug & cosmetic act of 1938

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14
Q

the food, drug & cosmetics act assures that food & cosmetics are

A

safe, effective & properly labeled

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15
Q

Durham-Humphrey Amendment of 1951

A

amendment to the FDCA; created policy regarding OTC & Rx status, how RX were to be dispensed, oral & written RX, refills, & dispensing directly by a practitioner

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16
Q

created legend (Rx) drugs

A

Durham-Humphrey amendment of 1951

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17
Q

kefauver-harris amendments of 1962

A

Thalidomide disaster of 1962; drug efficacy amendmentsl proof of effectiveness, proof of safety, goof manufacturing practices, drug advertising, investigational drug procedures

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18
Q

drug abuse control amendments of 1965

A

precursor to controlled substances act of 1970; controlled use of depressants, stimulants & hallucinogens (nothing really came from it)

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19
Q

comprehensive drug abuse prevention & control act of 1970

A

consolidated enforcement agencies-> DEA 1973

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20
Q

medical device amendment of 1976

A

broadens the FDA authority by requiring safety & effectiveness of life-sustaining & life-supporting devices (pre-market approval)

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21
Q

orphan drug act of 1983

A

facilitate commercialization of drugs for rare diseases

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22
Q

rare disease

A

one that affects 200,000 in US & for which there is no reasonable expectation of recovering the developments cost of the drug

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23
Q

Prescription Drug Marketing act of 1987

A

bans sale, trade or purchase of samples, mandates storage, handling & record-keeping requirements of drugs; establishes criminal & civil penalties for violations of the act
prohibits resale of RX meds purchased by hospitals

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24
Q

safe medical devices act of 1990

A

granted FDA broader authority- recall a device that would cause serious health consequences of death; user is required to report adverse events to FDA in 10 days

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25
Q

dietary supplement health & education act of 1994

A

dietary supplements defines as a special class of food

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26
Q

food & drug modernization act of 1997 (FDAMA)

A

RX only wording; pediatric studies of drugs, pharmacy compounding, PET compounding, expediting study & approval of fast track drugs; info program on clinical trials for serious of life-threatening diasease

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27
Q

OTC labeling requirement 1999

A

requires new, easy to read, standardized OTC drug info

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28
Q

food & drug administration amendments act (FDAAA) of 2007

A

expand FDA authority to ensure it can conduct complex & comprehensive reviews of new drugs & devices; encourage research & development for peds treatment; (PDUFA, MDUFMA, BPCA, PREA). trace & track technologies

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29
Q

poison prevention packaging act of 1970 (PPPA)

A

prevent accidental poisoning of young children

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30
Q

responsible for implementation of PPPA

A

US consumer product safety commission (CPSC)

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31
Q

non-compliant means

A

doesn’t have child safety cap

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32
Q

may be non-compliant if:

A
  • manufacturer also supplies substance in packages which no comply
  • the packages have labeling stating “for households without young children”
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33
Q

omnibus budget reconciliation act of 1990 (OBRA)

A

establishment of a drug review program by states- standards for counseling for medicaid pts; DUR, maintain pt records, review boards for medicaid

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34
Q

anabolic steroids control act 1990

A

required drugs related to testosterone that promotes muscle growth be schedule III

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35
Q

Health insurance portability & accountability act (HIPAA)1996

A

aka kennedy-kassenbaum act; privacy, security, transaction ad code sets & identifier rules

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36
Q

unique identifier rules

A

establish uniform #s for patients, providers, health plans & employers

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37
Q

transaction & code sets rules

A

standard format used to communicate using a standardized coding system

38
Q

security standards

A

safeguards in place concerning storage, maintenance, transmission & access to PHI

39
Q

Privacy standards

A

limit use & release of PHI

40
Q

federal food, drug & cosmetic act (FDCA) is designed to

A

protect public health

41
Q

FDCA requirements

A

F&C be safe & properly labeled, medical devices be safe & effective, comply with CGMP, FDA enforces it, OTC be labeled & safe, seizure of misbranding & adulterated drugs, FDA can perform limited inspections of pharmacies, broad over other stuff

42
Q

misbranding

A

dispensing of a drug for distribution in violation of labeling requirements

43
Q

adultered

A

drugs containing filthy, putrid & decomposed substances & drugs packed & held under unsanitary conditions

44
Q

types of drugs covered under the FDCA

A

legend/RX drugs, OTC, controlled substances, third class of drugs

45
Q

third class of drugs

A

prescriptive authority for pharmacists

46
Q

pharmacists who engage in manufacturing must

A

register with the FDA & file a list of drugs manufactured every 6 months

47
Q

most common example of misbrandingis when

A

a pharmacist refills an RX w/out authorization from the prescrier

48
Q 
recall classifications
class I
A

for products that will cause serious FATAL consequences

49
Q 
recall classifications
class II
A

for drugs or devices that may cause serious but REVERSIBLE effects

50
Q 
recall classifications
class III
A

for products that are not likely to cause adverse health effects

51
Q

3 basic forms of regulatory action FDA can impose

A
  1. injunction or restraining order from a court- civil procedure
  2. seizure or embargo- civil procedure
  3. regulatory letter- administrative action by FDA
52
Q

Who orders a drug recall?

A

manufacturer or distributor

FDA CANNOT do it!

53
Q

patient package insert (PPI) required to be dispensed with

A

isoproterenol, oral contraceptives, oral postcoital contraceptives, injectible contraceptives, estrogens, progestagional drug products

54
Q

record keepeing (FDCA)

A

must keep record when drugs arrive at pharmacy, sit in pharmacy & leave pharmacy

55
Q

new drug if:

A

new chemical, new dosage form, new medical claim, new dosage level, new/novel packaging material

56
Q

phase I of new drug

A

looking for safety, some early ideas on route of administration

57
Q

phase II of new drug

A

30-50 pts; have the disease you are trying to treat

58
Q

phase III of new drug

A

huge, multi-site, data collection process; usually blinded; safety & efficacy for intended use studied

59
Q

phase IV pf new drug

A

drug has hit the market- post market studies

60
Q

National Drug Code (NDC) is requested

A

but not required in and on all drug labeling

61
Q

how many digits(characters) are in an NDC?

A

10

62
Q

labeler code of NDC

A

first 5 numbers- unique for the company that makes it

63
Q

drug product code 0f NDC

A

middle numbers- unique for drug & strength

64
Q

package of NDC

A

3rd section- package size

65
Q

label

A

upon the immediate container

66
Q

labeling

A

all labels & other material that accompanies drug

67
Q

RX label must hav

A

name & address of dispenser(pharmacy), serial number of RX, date, Dr name, pt name, direction, precautions

68
Q

not required by federal law; left to discretion of states

A

pt address, pharmacist initials, pharmacy #, drugs name, strength & lot #, BUD, manufacturer/distributor

69
Q

prescription drug exemption

A

legend drugs in bulk containers not intended for pt use, manufacturer is exempt from some labeling

70
Q

LABEL on manufacturer container of RX-only drug must contain:

A

name, quantity of each active ingredient, declaration of new quantity, statement of usual dosage, RX only. route if not oral, habit-forming, lot #, exp date

71
Q

LABELING on manufacturer container of RX-only drug must contain:

A

description (names), pharmacology, indications & usage, CIs, warnings, precautions, adverse rxns, drug abuse/dependence, overdose, dosage, how supplied, date of most recent revision of labeling

72
Q

unit dose labeling- on actual container

A

name & quantity of active ingredient per dosage unit, exp date, lot #, name & place of business `of manufacturer, pack or distributor, any statement required by compendia

73
Q

drugs facts pamphlet

A 
drug facts- title
active ingredients- inc. amount
purpose
use
warning
directions
other info
inactive ingredients
?- phone #
74
Q

pharmaceutical alternative

A

drug products that contain same therapeutic moiety but may contain different salts, esters, complexes, dosage forms, strengths

75
Q

orange book

“A” rated products

A

bioequivalent & therapeutically equivalent - can substitute

76
Q

orange book

“B” rated products

A

found not to be bioequivalent

77
Q

orange book

“AB” rated products

A

actual or potential bioequivalence problems- acceptable if resolved in vivo/invitro- meets “necessary BE requirements”

78
Q

orange book

AA

A

products not present bioequivalence problems in conventioal dosage forms

79
Q

orange book

AN

A

solutions & powders for aerosolization

80
Q

orange book

AO

A

injectable products with oil solvents

81
Q

orange book

AP

A

injectable solutions

82
Q

orange book

AT

A

topical products

83
Q

prego category A

A

studies failed to show risk to fetus

84
Q

prego category B

A

animal studies failed to show risk, no human studies

85
Q

prego category C

A

animal studies show adverse effects on fetus- potential benefits may out way risk, no human studies

86
Q

prego category D

A

positive human fetal risk-potential benefits may out way risks

87
Q

prego category X

A

studies in animals & humans show fetal abnormalities- risks clearly out way benefits

88
Q

what prompted the orphan drug act?

A

AIDS

89
Q

drug price competition & patent term restoration act of 1984

A

aka Waxman-hatch act.

ANDA, patent extension, decreased time necessary to approve generic drugs

90
Q

file IND

A

after animal studies before human studies

Law (8 decks)

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