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Federal Law Overview Flashcards

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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
dietary supplement health & education act of 1994
dietary supplements defines as a special class of food
26
food & drug modernization act of 1997 (FDAMA)
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
27
OTC labeling requirement 1999
requires new, easy to read, standardized OTC drug info
28
food & drug administration amendments act (FDAAA) of 2007
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
29
poison prevention packaging act of 1970 (PPPA)
prevent accidental poisoning of young children
30
responsible for implementation of PPPA
US consumer product safety commission (CPSC)
31
non-compliant means
doesn't have child safety cap
32
may be non-compliant if:
- manufacturer also supplies substance in packages which no comply - the packages have labeling stating "for households without young children"
33
omnibus budget reconciliation act of 1990 (OBRA)
establishment of a drug review program by states- standards for counseling for medicaid pts; DUR, maintain pt records, review boards for medicaid
34
anabolic steroids control act 1990
required drugs related to testosterone that promotes muscle growth be schedule III
35
Health insurance portability & accountability act (HIPAA)1996
aka kennedy-kassenbaum act; privacy, security, transaction ad code sets & identifier rules
36
unique identifier rules
establish uniform #s for patients, providers, health plans & employers
37
transaction & code sets rules
standard format used to communicate using a standardized coding system
38
security standards
safeguards in place concerning storage, maintenance, transmission & access to PHI
39
Privacy standards
limit use & release of PHI
40
federal food, drug & cosmetic act (FDCA) is designed to
protect public health
41
FDCA requirements
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
misbranding
dispensing of a drug for distribution in violation of labeling requirements
43
adultered
drugs containing filthy, putrid & decomposed substances & drugs packed & held under unsanitary conditions
44
types of drugs covered under the FDCA
legend/RX drugs, OTC, controlled substances, third class of drugs
45
third class of drugs
prescriptive authority for pharmacists
46
pharmacists who engage in manufacturing must
register with the FDA & file a list of drugs manufactured every 6 months
47
most common example of misbrandingis when
a pharmacist refills an RX w/out authorization from the prescrier
48
``` recall classifications class I ```
for products that will cause serious FATAL consequences
49
``` recall classifications class II ```
for drugs or devices that may cause serious but REVERSIBLE effects
50
``` recall classifications class III ```
for products that are not likely to cause adverse health effects
51
3 basic forms of regulatory action FDA can impose
1. injunction or restraining order from a court- civil procedure 2. seizure or embargo- civil procedure 3. regulatory letter- administrative action by FDA
52
Who orders a drug recall?
manufacturer or distributor | FDA CANNOT do it!
53
patient package insert (PPI) required to be dispensed with
isoproterenol, oral contraceptives, oral postcoital contraceptives, injectible contraceptives, estrogens, progestagional drug products
54
record keepeing (FDCA)
must keep record when drugs arrive at pharmacy, sit in pharmacy & leave pharmacy
55
new drug if:
new chemical, new dosage form, new medical claim, new dosage level, new/novel packaging material
56
phase I of new drug
looking for safety, some early ideas on route of administration
57
phase II of new drug
30-50 pts; have the disease you are trying to treat
58
phase III of new drug
huge, multi-site, data collection process; usually blinded; safety & efficacy for intended use studied
59
phase IV pf new drug
drug has hit the market- post market studies
60
National Drug Code (NDC) is requested
but not required in and on all drug labeling
61
how many digits(characters) are in an NDC?
10
62
labeler code of NDC
first 5 numbers- unique for the company that makes it
63
drug product code 0f NDC
middle numbers- unique for drug & strength
64
package of NDC
3rd section- package size
65
label
upon the immediate container
66
labeling
all labels & other material that accompanies drug
67
RX label must hav
name & address of dispenser(pharmacy), serial number of RX, date, Dr name, pt name, direction, precautions
68
not required by federal law; left to discretion of states
pt address, pharmacist initials, pharmacy #, drugs name, strength & lot #, BUD, manufacturer/distributor
69
prescription drug exemption
legend drugs in bulk containers not intended for pt use, manufacturer is exempt from some labeling
70
LABEL on manufacturer container of RX-only drug must contain:
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
LABELING on manufacturer container of RX-only drug must contain:
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
unit dose labeling- on actual container
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
drugs facts pamphlet
``` drug facts- title active ingredients- inc. amount purpose use warning directions other info inactive ingredients ?- phone # ```
74
pharmaceutical alternative
drug products that contain same therapeutic moiety but may contain different salts, esters, complexes, dosage forms, strengths
75
orange book | "A" rated products
bioequivalent & therapeutically equivalent - can substitute
76
orange book | "B" rated products
found not to be bioequivalent
77
orange book | "AB" rated products
actual or potential bioequivalence problems- acceptable if resolved in vivo/invitro- meets "necessary BE requirements"
78
orange book | AA
products not present bioequivalence problems in conventioal dosage forms
79
orange book | AN
solutions & powders for aerosolization
80
orange book | AO
injectable products with oil solvents
81
orange book | AP
injectable solutions
82
orange book | AT
topical products
83
prego category A
studies failed to show risk to fetus
84
prego category B
animal studies failed to show risk, no human studies
85
prego category C
animal studies show adverse effects on fetus- potential benefits may out way risk, no human studies
86
prego category D
positive human fetal risk-potential benefits may out way risks
87
prego category X
studies in animals & humans show fetal abnormalities- risks clearly out way benefits
88
what prompted the orphan drug act?
AIDS
89
drug price competition & patent term restoration act of 1984
aka Waxman-hatch act. | ANDA, patent extension, decreased time necessary to approve generic drugs
90
file IND
after animal studies before human studies

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