1
Q
What is the DEA Form 106 used for?
A
Lost or theft of CS
Must notify the DEA in writting within 1 business day of discovery. Then fill out the 106 form within 45 days.
2
Q
If a 222 form is lost or stolen, what should be done?
A
Execute another 222 and attach a statement
The statement must indicate the loss and be retained.
3
Q
What is the maximum daily limit for pseudoephedrine sales?
A
3.6g per day
4
Q
What is the maximum monthly limit for pseudoephedrine sales?
A
9g
4
Q
How long must PSE logbook records be kept?
A
2 years
5
Q
What is the max pharmacist to tech ratio without special request?
A
1:2
The PIC can request a 1:5 ratio if sufficient certified techs are available.
6
Q
A pharmacist license must be renewed ______
A
Annually on December 31st
-15 hrs total (can carry over 5hrs
-5 hrs of live CE
-3 hrs related to vaccines if immunizing
7
Q
What must be reported to the state immunization register within 72 hours?
A
Non-flu vaccine administration
Patients must also receive the VIS form.
8
Q
What is the training requirement for non-certified techs?
A
Training within 180 days of being hired
Must register with the BOP within 30 days of completion.
9
Q
What is the max quantity for a targeted CS prescription for acute pain?
A
5 days
7 days if post-operative
10
Q
If a pharmacy closing unexpectedly for more than 2 hours the must_________.
A
Notify BOP and patients with instructions on how to access pharmacy services during closure
11
Q
What immunizations can be given without a rx?
A
CDC-recommended vaccines for >18 years old
12
Q
What immunizations can be given with an rx?
A
Any CDC recommended vaccine to patients 6 or older
13
Q
What is the max working hours for pharmacy staff per day?
A
12 hours
Must have a 30 min lunch break if working >6 hrs.
14
Q
What is the CE requirement for a Clinical Pharmacist Practitioner (CPP) license?
A
35 hours of CE annually
Must be approved by BOP.
15
Q
What must be included in the Privacy Notice for HIPAA?
A
-How pharmacy will use and disclose PHI
-Individual’s rights
-Pharmacy’s legal duties with respect to the law
-Who to contact for more information
-Effective date
16
Q
What is the initial training requirement for sterile compounding?
A
Media fill testing no less than 3 separate times in a row
17
Q
Retesting requirements for sterile compounding of Categories 1 & 2
A
every 6 months
18
Q
Retesting requirements for sterile compounding of Category 3
A
every 3 months
19
Q
Retesting requirements for non-sterile compounding
A
every 12 months
20
Q
What is the max quantity for a CII prescription when written for a patient leaving the country?
A
No max quantity
Verify with provider before filling.
21
Q
When can a CII prescription be faxed?
A
Only for LTCF, hospice, or compounded products for direct administration
22
Q
What is the BUD for Cat 1 when prepared in a PEC?
A
BUD ≤ 12hrs at room temp or 24hrs refrigerated
23
Q
What is the BUD for Cat 2 when prepared in a clean room?
A
BUD > 12hrs at controlled temp and > 24hrs refrigerated
24
How often is air sampling conducted for Cat 1 and Cat 2?
Every 6 months
25
How often is air sampling conducted for Cat 3?
monthly
26
How often is surface sampling conducted for Cat 3?
Weekly
27
How often is surface sampling conducted for Cat 1 and Cat 2?
Monthly
28
What is the primary engineering control (PEC) used in compounding?
* Laminar airflow workstation (LAFW)
* Compounding aseptic containment isolator (CACI)
29
What is the ISO classification for the Buffer Area?
ISO 7
## Footnote
The Buffer Area is critical for maintaining sterile conditions.
30
What is the ISO classification for the Ante Area?
ISO 7/8
## Footnote
The Ante Area serves as a transition zone for personnel and materials.
31
What must be worn when compounding Hazardous Drugs (HDs)?
* Fit-tested N95
* Gloves (2 pairs of chemo gloves)
* Disposable gowns
* Shoe cover (2 pairs)
* Goggles
32
How often should chemo gloves be changed when compounding HDs?
Every 30 mins or when torn, punctured, contaminated
33
How often should gowns be changed when compounding HDs?
Every 2-3 hours or immediately if soiled
## Footnote
Gowns must be disposable and cannot be worn to other areas.
34
True or false: Unpacking from shipping containers can be done in a sterile room.
FALSE
## Footnote
Unpacking must occur in a neutral/normal or negative pressure room.
35
True or False: Prep of a HD can be done outside of a negative pressure area.
False
## Footnote
This ensures containment of hazardous materials.
36
BUD date for a multiple-dose container
28 days
37
BUD for a single dose container
12 hours of opening (in or outside of an ISO 5)
**must be punctured within ISO 5
38
BUD for non-preservative aqueous dosage forms
14 days in refrigerator
39
BUD for aqueous dosage forms with preservatives
35 days room temp or refrigerated
40
BUD for non-aqueous dosage forms of oral liquids
90 days room temp or refrigerated
41
BUD for non-aqueous dosage forms of non-oral liquids
180 days room temp or refrigerated
42
Compounding record must include:
-Name/strength/dose form of the preparation
-Master formulation used for reference
-Info of components used
*Sources
*Lot #
*Expiration dates
-Total qty
-Name of person that who prepared the product
-Name of person who did quality control
-Date prepared
-Rx number
-BUD
-Documentation of any issues reported by patient
43
Master formulation must include:
-Name/strength/dose form of the preparation
-Calculations
-Compatibility/stability info
-Mixing instructions
-Sample labeling info
*BUD
*Storage conditions
*Container for dispensing
*Description of final preparation
44
True or False: General compounding is subject to FDA approval or Current Good Manufacturing Practices.
False
45
True or False: Outsourcing facilities are subject to Current Good Manufacturing Practices.
True
*Can make large batched, not for individual use
*Many compound drug products for health care practitioners to have on-hand
*Can also make for individual patients
*Can do sterile and non-sterile
46
Standing orders from the BOP for the following medications:
-Nicotine replacement therapy that is approved by the United States Food and Drug Administration
-Self-administered oral or transdermal contraceptives
-Prenatal vitamins
-Post-exposure prophylaxis medications for the prevention of human immunodeficiency virus (HIV)
-Glucagon for the treatment of severe hypoglycemia
47
DEA registration must be renewed_____years.
3 years
**if expired you have no grace period. You must stop handling controls immediately.
48
If a pharmacy transfers its business operations it must submit info regarding transfer to the DEA _____ in advance
14 days
49
True or False: If the pharmacy can demonstrate low probability that PHI has been compromised it is NOT considered a PHI breach.
True
50
CIII-CV counts may be estimated if:
-Bottle is open
-Contains < 1000
## Footnote
**Exact count for bottle >1000**
51
True or False: Unintentional acquisition, access, or use of PHI by pharmacist made in good faith and within the scope of authority IS a PHI breach
False
52
True or False: Inadvertent disclosure of PHI by a person who is authorized to access the PHI to someone who is also authorized to access the PHI is NOT considered a PHI breach.
True
53
True or False: If the pharmacy has a good faith belief that the unauthorized person is unable to retain the information it is NOT considered a PHI breach.
True
54
Flu and COVID allowed without Rx through protocol for patients ____
7 and older
55
After consulting the provider, you can change the following on a CII:
* Patient’s address
* Drug strength
* Dosage form
* Qty
* Directions for use
56
After consulting the provider, you can add the following on a CII:
Date written
57
CII Rx expires within ___months and can have ___refills
6 months and 0 refills
58
CIII-CIV Rx expires within ___months and can have ___refills
6 months and 5 refills
59
True or False: CV does not expire with in 6 months and can have >5 refills
True
60
Pharmacist can do an emergency refill of everything (except a CII) for up to ____ days
30 days
**must notify the provider within 72 hours
***can do this for CIII-CV
61
Tech license must be renewed____
Annually on December 31st
**2 hrs of vaccine related CE annually if immunizing
62
Intern license must be renewed___
Annually on September 1st
63
Rx records must be kept for____
3 years
*separate CII, CIII-V, and non-CS*
64
CS inventory records must be kept for ____
2 years
*must be kept separate from other records
65
222 Forms and invoices for CS must be kept for _____
2 years
66
BOP must be notified within ____ of change in pharmacy personnel
30 days
67
BOP must be notified within ____ of a pharmacist's change in employment
30 days
68
BOP must be notified within ____ of a pharmacist's change in address
30 days
69
BOP must be notified within ____ of Rx dispensed that caused or contributed to the death of a patient
14 days
70
BOP must be notified within ____ of disasters, accidents or theft
10 days
* NC BOP Drug Disaster & Loss Report for CS or non-CS
*DEA Form 106 for CS plus ^
71
BOP must be notified within ____ if responding to inspection deficiencies
30 days
72
BOP must be notified within ____ of a certified tech being hired at a new location
10 days (of beginning employment)
73
Pharmacists under BOP investigation for med error must have their pharmacy provide documentation to the BOP within _____
10 days of written notice
74
Pure Food and Drug Act of 1906
The creation of the FDA and accurate labeling of certain drugs
75
Food Drug & Cosmetic Act 1938
FDA to provide regulation to ensure safety of food, drugs, etc.
76
Humphrey-Durham Amendment of 1951
Classified drugs as ‘prescription only’ and OTC
77
Kefauver-Harris Amendment of 1962?
That a drug is both safe and effective
78
Omnibus Budget Reconciliation Act of 1990 (OBRA '90)
Created requirement for DUR and patient counseling
79
Request for rx recorders made by a certified diversion investigator must be provided within ____
2 days
80
Records on medication errors must be kept for _____
3 years
81
Record of identifying information for CII pick up
3 years
82
A hospital pharmacy that prepares sterile compounds must ensure that its products maintain their labeled strength within____
10% of the listed strength, or better if specified in the monograph limits
83
Primary engineering controls should be cleaned _____
every 30 minutes as long as it doesn't disrupt compounding
84
If water-containing compounded sterile product is nonsterile during any phase, it must be sterilized within ______ of completion of the preparation
6 hours
85
Immediate-use (emergency situation) is exempt from some requirements (garbing and ISO air) as long as:
-no more than 3 products (ingredients)
-admin begins withing 4 hrs
## Footnote
*cannot be stored for any period of time (no advanced prep)
86
Patient profiles must be kept for ______
3 years
87
True or False: Equipment (or parts of equipment) that comes in direct contact with HDs must be dedicated for use with HDs.
True
88
True or False: Equipment that does not come in direct contact with HDs may be shared between HD and non-HD compounding areas provided it is deactivated, decontaminated, and cleaned before it is removed from the HD area.
True
89
True or False: Immediate-use sterile compounds cannot be batched for more than one patient.
False
*can if requirements are met
90
The dispensing record for an automated dispensing system at a LTCF must include:
-Date removed
-Drug name
-Drug strength
-Drug dosage form
-Qty removed
-Patients name
-Who removed the drug
91
True or False: ID is required for picking up CS
True
*must document name of person picking up and ID number
92
Record of identifying information for CII pick up must be kept for _____
3 years
93
Master formulation record is required when ____
-When CSP is made for more than 1 patient
-Contains non-sterile ingredients
94
The BOP be notified within____ of a pharmacy's permanet closure.
10 days
95
Record of fridge temps must be kept for____
2 years
96
Office of Inspector General (OIG) Exclusion list signifies that the pharmacist may not participate in_____
federally funded reimbursement programs
97
Combat Methamphetamine Epidemic Act includes:
-Ephedrine
-Pseudoephedrine
-phenylpropanolamine.
98
Composition of NC Board of Pharmacy
6 members (all NC residents): 5 RPhs, 1 public representative
99
Who appoints members of BOP?
The Governor
100
Types of suspension imposed by Board
1. Active - Rph does not practice during specified amt of time
2. Stayed - “probation,” must not violate any laws during specified amount of time, but allowed to practice
3. Summary - immediate suspension of license before hearing occurs
101
How long can an RPh serve as temporary pharmacy manager?
90 days
102
Does a pharmacist at an out-of-state pharmacy mailing to NC patient need to be licensed in NC?
No
*They must be licensed in state where dispensing occurs
*Pharmacy must have NC permit
103
Pharmacy permits must be renewed_____
Annually on 12/31
## Footnote
*Expire 60 days after (grace period until 3/1)
104
OTC insulins
o Regular insulin (Humulin R & Novolin R)
o NPH (Humulin N & Novolin N)
o 70/30 mixtures (Humulin 70/30 & Novolin 70/30)
105
Codeine behind-the-counter sales
-Max qty of 200mg/100ml
-Max of 240ml (8oz) per 48 hours
106
Codeine Logbook must include:
-Purchaser’s name
-Purchaser's address
-Date of sale
-Product name
-Quantity sold
-Pharmacist’s initials
## Footnote
*Can be dispensed by a pharmacist only
107
Pathways for Clinical Pharmacist Partitioner License approval by the BOP:
* hold a board of pharmacy specialty certification
* complete a ASHP Residency and have 2 years of clinical experience
* have a doctor of pharmacy degree with three years of clinical experience plus a certificate program
108
Mast formulation record is required when:
When CSP is made for more than 1 patient
Contains non-sterile ingredients
109
Pseudoephedrine records must include:
-Name of purchaser
-Address of purchaser
-Date of sale
-Time of sale
-Name of product
-Qty sold
110
Patients must be notified of a HIPPA breach within___
60 days
111
Max quantity of Paregoric
2 oz in 24 hours
112
Emergency departments can dispense a ____supply of drugs to meet the immediate needs of the patient.
24 hr supply
113
An impaired pharmacist recovery program in NC is established under:
L. Stanley Haywood Recovery Fund
114
Codiene is a CIII at a qty of ____
less than 1.8gm per 100mL
115
The prescriber may authorize this agent to fax an rx as long as it includes_____
The name of the transmitting agent
116
True or False: PSE sale restriction does NOT apply to any PSE product that is in the form of a liquid, liquid capsule, gel capsule, or pediatric product intended for use for child under 12 years of age?
True
117
PSE sales must be electronically submitted to the National Precursor Log Exchange (NPLEx) administered by the National Association of Drug Diversion Investigators (NADDI) ________
Weekly
118
Anti-neoplastic drugs shall be compounding in ______
Vertical flow, class II, biological safety cabintet
119
CE records must be kept for ____
3 years
120
Starter doses from a physician's office is limited to a ____
24 hour supply
121
Physicians and immunizing Pharmacist must review the vaccine protocol ______
Annually
122
Information reported to the PMP includes:
Name
Full address
telephone number
date of birth
date written
date filled
rx number
whether the rx is new or a refill
qty
day supply
NDC
Prescriber’s DEA number
Prescriber’s NPI
Method of payment
123
Nabilone
Cesamet CII
124
Meperidine
Demerol CII
125
Remifentanil
Utiva CII
126
Phendimetrazine
Bontril CIII
127
Benzphetamine
Direx CIII
128
Meprobamate
Miltown CIV
129
Carisoprodol
Soma CIV
130
Butorphanol
Stadol CIV
131
Pentazocine
Talwin CIV
132
Triazolam
Halicon CIV
133
Zaleplon
Sonata CIV
134
Chlordiazepoxide
Librium CIV
135
Flurazepam
Dalmane CIV
NC MPJE
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