federal Flashcards

(38 cards)

1
Q

every pharmacy that dispenses must be registered with DEA through what form

A

224

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2
Q

how often does CS registration need to be renewed

A

every 3 years

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3
Q

a pharmacy that plans to transfer operations must submit info to the DEA at least how many days in advancd

A

14

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4
Q

on the date of transfer of business, what must be taken

A

complete CS inventory

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5
Q

transferring C2 (not rx) to another pharmacy requires what form

A

DEA 222

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6
Q

DEA form is a ___ sheet

A

single
-triplicate is DC

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7
Q

what is the only electronic means to order C2

A

CSOS

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8
Q

can you use csos to order C3-5

A

yes

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9
Q

when items are received, purchaser (pharmacy) must document number of items received and what else

A

person receiving must sign and date the invoice/receipt

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10
Q

222 forms and records of CS orders can be kept with all other records and how long do you keep them

A

false, have to maintained separately and kept for 2 years

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11
Q

how can inventory of C2 drugs be determined

A

actual physical count

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12
Q

after initial inventory, registrant is required to take a new inventory at least every ____ years

A

2 but iowa requires annually

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13
Q

rx for a CS must be dated on the _____ date issued (even if theres a different do not fill date)

A

true

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14
Q

what does it mean when “the true prescribers DEA number must always be listed”

A

if a PA writes a rx for a CS and the PA has a supervising physician, its the DEA # of the PA that must be on the rx

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15
Q

a pharmacy may dispose of its CS inventory in the following ways

A

-destroy using on-site method
-deliver or allow pickup to a reverse distributor
-assistance from special agent in charge in the area
-for return or recall: deliver to from where it was obtained, reigstered manu of sub or another registrant

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16
Q

pharmacy may transfer CS to who for disposal

A

DEA registered reverse distributor

17
Q

authorized collectors for CS destruction may receive them from

A

-ultimate user
-a person entitled to dispose of an ultimate users property
-from LTC

18
Q

who can become authorized as a collector

A

retail
hospitals/clinics with on site pharmacies

19
Q

central fill pharmacies are permitted to prepare both _____

A

initial and refill rx
*as long as a contract is in place or common owner with a retail pharmacy

20
Q

central fill pharmacies must have a label on the package saying what

A

RETAIL pharmacy name/addr
unique identifier (DEA #)

21
Q

T/F only either the CF or retail pharmacy need to keep records

A

false, both need to

22
Q

following criteria may indicate a forced rx
-rx looks too ___
-___, __, __ differ from usual medical usage
-rx does not comply with acceptable ______
-rx appears to be ____
-directions are written with no ____
-rx is written in different ____ or in different ____

A

-good
-quantity, directions, or dosages
-abbreviations
-photocopied
-abbreivations
-color inks or handwriting

23
Q

what form is used to record CS destruction

24
Q

what form is used for ordering/transferring CS

25
what form is used for a pharmacys registration with DEA to be authorized to obtain/dispense CS
224
26
REMS is focused on ____,___, and ___ a serious risk by education to reduce the severity of an event---- is NOT designed to mitigate ALL _____
preventing, monitoring, and managing adverse events
27
do all drugs have the SAME rems requirements
no, different
28
in order to dispense a REMS drug, the pharmacist is require to be
certified in that specific REMS
29
pt may be required to do what before rph can authorize to dispense REMS drug
monthly lab tests
30
can a rems drug be subject to a day supply limit
yes
31
what must a privacy practice notice contain
-how pharm will use PHI -indiv rights -effective date of notice -who the person may contact for more info -pharmacys legal duty to respect law
32
what is a breach
use or disclosure that compromises privacy of persons PHI
33
following a breach, pharmacy must notify the indiv within
60 days
34
notice of privacy practices -must be provided to _____ that asks for it -must be made available on pharmacys ____ -may be ____ to a pt if the pt has agreed to receive it by ___
-anyone -website -emailed/email
35
what is a class 1 recall
dangerous product that could cause SERIOUS problems
36
what is a class 2 recall
product MAY cause TEMP health problem or slight threat
37
what is a class 3 recall
unlikely to cause any adverse health rxn but VIOLATES FDA label/manu
38
what must a VIS have documented
-edition date of vis -date vis is provided -name/title of pt admin -manu and lot #