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Law Flashcards

(133 cards)

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1
Q

how long do records need to be kept via Ohio law

A

3 years

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2
Q

how long do records need to be kept via FDA law

A

2 years

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3
Q

when is it legal to send a rx from computer to fax machine

A

rx operates within a closed system

computer to computer system is down

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4
Q

when does a pharmacist not have to disclose the price of a drug

A

schedule 2 drugs

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5
Q

How long does a pharmacy have to retrieve records to be reviewed

A

3 business days

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6
Q

At what point does a pharmacy need a wholesaler license

A

5% rule

  • if a pharmacy buys $$$ worth of drug and sells 5% to someone other than their own patients they need a wholesaler license
  • anything less than 5% is considered occasional sale
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7
Q

Define prescription drug

A

habit forming

unsafe for use except under the supervision of a practicioner

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8
Q

What will be the expiration date on a prescription

A

1 year from the dispensing date
or
manufacturer’s expiration date whichever is shorter

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9
Q

how long is a consult agreement effective for

A

2 years

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10
Q

who can participate in a consult agreement

A

ohio licensed pharmacists
ohio licensed physicians
no PAs
no APNs

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11
Q

how long do you have to notify the board if the pharmacists in a consult agreement is no longer authorized to prescribed controlled substances

A

5 days

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12
Q

once a pharmacist obtains a valid DEA registration to prescribe how many days to they have to notify the board

A

30 days

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13
Q

when does an OARRs report need checked when prescribinh

A

adding a controlled substance

adjusting a controlled substance

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14
Q

how often can a pharmacists provide an emergency prescription

A

once per prescription
or
once per year if it’s a 30 day supply

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15
Q

what is the amount of drug that can be given in an emergency prescription

A

72-hour, except C2

30-day if it’s a consistent drug

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16
Q

how many attempts do you have to pass the NAPLEX and MJPE

A

5

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17
Q

when must an intern notify the board and employer when they are no longer enrolled in a school of pharmacy

A

72 hours

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18
Q

after an intern is no longer enrolled when must they return their intern certificate to the board

A

10 days

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19
Q

intern and pharmacist license renewal date

A

september 15

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20
Q

how many days do you have to notify the board of a name change

A

30

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21
Q

how many days do you have to notify the board of a change of address

A

30

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22
Q

how many days do you have to notify the board of a change of employment

A

30

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23
Q

how many days do you have to notify the board for a change in responsible pharmacist

A

10

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24
Q

how many days in advance must you notify the board to discontinue business

A

30

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25
what date do terminal distributers renew licenses
april 1
26
what date do wholesaler's renew licenses
july 1
27
what date do laboratory terminal distributors renew licenses
april 1
28
what date must a rx be filled from issuance
6 months
29
max number of non-controlled substances that can be written on one rx
3
30
drugs encompassed by a category 1 license for terminal distributors
single dose injections of IV fluids
31
Drugs encompassed by a category 2 license for terminal distributors
any dangerous drug | + category 1 drugs
32
Drugs encompassed by a category 3 license for terminal distributors
controlled substances | + category 1 & 2 drugs
33
how many CE hours are required
40 hours every 2 years
34
how many hours are required of patient safety/medication errors
2 hours
35
When do CE hours need to be reported
sept 15 of the year they are due
36
how many CE hours of law are required
2 hours
37
how long can your license lapse before you have to retake the naplex and mjpe
3 years
38
how many days does a pharmacist have to notify the MD of interchangeable biological product is substituted
5 days
39
what does the orange book include
FDA generic bioequivalence
40
What does the purple book include
FDA list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations
41
can you transfer a c2 escript if its never been filled
yes
42
What are the items required on an outpatient label (10)
``` name and address of dispenser directions full name of patient full name of prescriber date of dispensing cautions Rx number drug name and strength quantity state if compounded ```
43
What 2 items are required on a small container within a prescription
rx number | patient name
44
What items are required on an inpatient unit dose prescription (6)
``` name of drug route of administration if not oral strength lot number and expiration date manufacturer or repacker special storage conditions ```
45
requirements for IV bags inpatient (6)
``` patient name name and amount of solution name and amount of drug expiration date or BUD name and address of pharmacy cautionary statements ```
46
requirements for IV bags outpatient (11)
``` name and address of pharmacy and phone number full patient name full name of prescriber directions and route date of dispensing any cautions name and volume of solution name and amount of drug quantity of the drug dispensed expiration date storage condition ```
47
what 3 things are required on a label for a sample
name of prescriber patient name directions
48
what 3 things on a C2 prescription that cannot be changed
patient name doctor drug name
49
how long does a pharmacy have to get rid of an outdated drug
1 year
50
how long does a wholesaler have to get rid of an outdated drug
2 years
51
What is an adulterated drug
1) physical conditions of the drugs, environment in which they were manufactured, anything unsanitary or damaged 2) if a drug leaves teh pharmacy and is then re-dispensed 3) outdated drugs
52
What needs to be completed on the date of discontinuing business of a pharmacy
complete controlled substance inventory
53
if missing/stolen drugs are controlled what must the pharmacist do
notify DEA immediately file form 106 within 1 business day
54
how many days does a pharmacy have to report a stolen controlled substance to the board
30 days
55
Can a patient donate drugs
no | a person donating an eligible drug may not have taken custody of the drug prior to the donation
56
can controlled substances be donated
no
57
What is the expiration date of a drug that can be donated
6 months or greater
58
who is eligible to receive donated drug
resident of ohio no 3rd party reimbursement or patient of a nonprofit clinic
59
what age can a pharmacist give an immunization to without a prescription
13
60
what age can a pharmacist give an immunization to with a prescription
7
61
what age can a pharmacist give a flu shot
7
62
what two records does a pharmacist need to give immunizations
successful completion of immunization course | BLS
63
anabolic steroids are what schedule of drug
3
64
can a practicioner request the drug name be omitted from the label
yes
65
records dating back to how long must be immediately retrievable
12 months
66
how many days do you have to retrieve records for the past 36 months
3 days
67
what happens to refills once a physician dies
patient can have one more refill
68
correct temperature for refrigerated products
2-8 degrees celsius
69
how many minutes do you have to submit a medical marijuana sale to oarrs
5 minutes
70
do naltrexone prescriptions need submitted to OARRS
only ones that are indicated for treatment of alcohol dependence or prevention of relapse to opioid dependence
71
when does OARRS need checked
adds a new/different OARRS substances to therapy OARRS has not been reviewed for 12 months prescriber from outside area patient from outside area rph beleives pt got more than one md in past 3 months pt showing s/sx of abuse
72
can you give an OARRS report copy to a MD?
no they must request their own | but you can talk to them about it and show them they just can't keep it
73
can an IPPE or an APPE be an OARRS delegate of the pharmacy
no, they must be a paid internship
74
what is ohio's MED threshold
80
75
what is USP 797
sterile products compounding chapter
76
What is USP 795
non-sterile products compounding chapter
77
any USP # under what is federally enforceable
1000
78
is it ok to bulk compound products and sell to other pharmacies
no it is illegal
79
when can a pharmacist compound a commercially available product
drug shortage pt needs med made without certain item pt needs a different dosage form
80
what is them max that a prescriber can have on hand of a compounded drug
72 hour supply limit
81
when can pharmacies compound for physicians use in office
treat emergency situations unanticipated procedures for which a time delay would negatively affect patient outcomes diagnostic purposes
82
what is the max MDs can have for in office use of a compounded topical product
60 grams or 60 mL | and only one container at a time
83
BUD for low risk compounds
48 hours at room temp 14 days when refrigerated 45 days frozen solid state
84
BUD for medium risk compounds
30 hours room temp 9 days when refrigerated 45 days frozen solid states
85
BUD for high risk compounds
24 hours room temp 3 days when refrigerated 45 days when frozen solid states
86
what 2 unique things are on a label for a compounded product
for direct patient administration only | not for resale
87
what is the days supply a vet can supply to a patient of a compounded product
7 days
88
Define charitable pharmacies
has terminal distributors' license is exempt from federal taxation is not a hospital
89
how much continuing education does a registered pharmacy technician need
10 hours total every 2 years 2 hours in pharmacy law 2 hours in medication safety
90
how many pharmacy technician trainees can a pharmacist supervise at one time
3
91
what must be done prior to prescribing opioids to minors
get informed consent
92
when does a MD not need informed consent when prescribing opioids to a minor
emergency treatment for surgery in a hospital
93
how long does a pharmacy have to notify the board if they start dispensing naloxone
30 days
94
what must a pharmacy have in order to provide lab testing or POC testing
certification through CLIA
95
how long does a pharmacist have to notify a MD that they gave a long term injectable drug
7 days
96
for an injectable drug (Not vaccine) is the pharmacy where it is dispensed also where the patient is required to get the inejection
No
97
how many days from the written date do you have to fill an opioid prescription
14 days
98
what is the max number of days an opioid Rx can be filled for
90 days
99
can you change the date on an opioid prescription
yes after calling the doctor
100
what is the supply limit a MD can prescribe opioids for acute pain
7 days
101
what is the supply limit a MD can prescribe opioids for acute pain for a minor
5 days
102
if an opioid is partially filled how long does a patient have to fill the rest of the prescription
30 days
103
what form is needed to order C2 drugs
DEA form 222
104
how many refills are allowed for C3s and C4s
5 refills or 6 months
105
what is the limit on selling a C5 as OTC when it was previously written as an RX
cannot sell if it was written as an rx in the past 6 months
106
What is DEA form 222
C2 ordering
107
What is DEA form 224
original registration for DEA license
108
What is DEA form 225
license to manufacture controlled substances
109
What is DEA form 224a
DEA re-registration form
110
What is DEA form 41
disposal of controlled substances
111
What is DEA form 106
theft or loss of controlled substances
112
how long does a pharmacy have to complete an annual inventory of controlled substances
13 months since previous inventory
113
When does a C 3,4,5 need to be estimated versus exact
<1000 can be estimated | >1000 must be exact
114
when a non-controlled substance becomes a controlled substance how long does the pharmacy have to do an inventory
10 days
115
what are reasons a pharmacy can partially fill a C2 and how long do they have to fill it
in a LTC, terminally ill = 6 months | requested = 30 days
116
what is the max number of pt a MD can treat how many pt with buprenorphine the first year and then years after
30 first year | 100 after that
117
what is the max number of days a MD can write a rx for weight reduction
30 days
118
what is required on label of OTC drugs
``` name of product name and address of manufacturer net contents name and amount of all active ingredients name of any habit-forming drug included cautions and warnings directions ```
119
what is a class 1 drug recall
will cause either serious AE or death
120
what is a class 2 drug recall
may cause temporary or medically reversible AE on health or where the probability of serious AE is remote
121
What is a class 3 drug recall
exposure is not likely to cause AE
122
max PSE allowed to be sold per day
3.6g
123
max PSE allowed to be sold per month
9 g
124
what is the 1906 pure food and drug act
prohibited the interstate commerce of adulterated foods and drugs
125
what is the 1911 shirley amendments
prohibited false and misleading claims for drug products
126
what is the 1938 federal food, drug, and cosmetic act
scientific proof of safety before a drug could be marketed
127
what is the 1951 durham-humphrey amendment
created two classes of products prescription and over the counter
128
what is the 1962 harris-kefauver amendments
scientific proof of efficacy
129
what is the 1983 orphan drug act
gave economic tax incentives for pharmaceutical manufacturers to develop drugs for rare diseases
130
what is the 1984 drug price competition patent restoration act
created the ANDA for generic drugs (prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting approval
131
What is the prescription drug marketing act of 1984
regulated samples cannot re-import drugs from other countries regulates who hospitals can sell to
132
what is the 1994 dietary supplement health and education act
made herbals officially dietary supplements
133
for immunizations what is the pharmacist to intern ratio
6:1
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