Law final exam: USP

Question 1

<795> Training and Evaluation Competencies

what are the 6 competancies

Have a
Great
Christmas & Sing
Happy tunes,
Michelle
Pray
Passionately

Answer 1

Hand Hygiene
Garbing
Cleaning and sanitizing
Handling and transporting components
Measuring and mixing
Proper use of equipment
Proper documentation

Question 2

<795> Steps of Training Process

what are the 2 types of safety documents

what does SOP stand for

Answer 2

Safety Documents:
*Safety Data Sheet (SDS)
- a detailed informational document prepared by the manufacturer or importer of a hazardous chemical. It describes the physical and chemical properties of the product.

*Certificates of Analysis (COA)
- a formal laboratory-prepared document that details the results of one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses

Standard Operating Procedures (SOP)
- provides clear-cut directions and detailed instructions needed to perform a specific task or operation consistently and efficiently.

Question 3

<795> Personnel Preparation

what must you remove
- outer
- rings..
- music

Hand Hygiene
- what must you wash your hands with
- how long must you wash your hands
- what must you dry your hands with

Answer 3

removed
- outer garments
- Jewelry including piercings
- Earbuds or headphones

Hand Hygiene
- Wash hands soap and water
- 30 seconds minimum
- Dry hands with disposable towels

Question 4

<795> Garbing

what must be worn for all compounding

additional PPE may be needed, what are they

Answer 4

Gloves
– Must be worn for all compounding

Additional personal protective equipment (PPE) as needed depending on the compound and risk of chemical exposure to the compounder:
Shoe covers
Head or hair cover
Facial hair cover
Face mask
Gown

*If the compounding is for a hazardous compound USP 800 PPE requirements are

Question 5

<795> Facility Requirements

what must the space for compounding be
- separate from what
- should it be messy and disorganized
- do you need a water source and if so what kind of water to be used for what

what must the facility have in order to be environmentally appropriate
- light
- temp and humidity
- temp. monitoring for what
- easily cleanable what

Answer 5

Space for compounding only
– Must be separate from sterile compounding
– Must be clean and organized
– Need a water source for cleaning
■ Purified water should be used to clean equipment and for any preparations requiring water

Environmentally appropriate
■ Good lighting
■ Appropriate temperature and humidity
■ Temperature monitoring daily for excursions of chemical storage
■ Easily cleanable floor, non- porous

Question 6

<795> Equipment

Must be in _____ and appropriate for _____ being made

if compounds can cause airborne chemical particles, what device must be used

what are the 2 types of closed-system processing devices to be added

how often should ventilation systems be certified?

Answer 6

Must be in good condition and appropriate for compounds being made

If compounds could cause airborne chemical particles a closed-system processing device needs to be added to this area.
– Containment ventilated enclosure (CVE)
– Biological Safety Cabinet (BSC)
■ Ventilation for these systems must be certified every 12 months

Question 7

<795> Cleaning Schedules

what must be cleaned if there is Visible soiled or suspected contamination

what must be cleaned after the spill

what must be cleaned every 3 months

what must be cleaned every 24 hours

what must be cleaned between compounds

Answer 7

Visible soiled or suspected contamination
- ceiling and walls
- Storage Shelving
- Floors
- Work Surfaces including Closed- System Processing Devices

after spill
- Storage Shelving
- Floors
- Work Surfaces including Closed- System Processing Devices

clean every 3 months
- Storage Shelving

clean every 24 hours
- Floors
- Work Surfaces including Closed- Closed-system processing Devices

clean Between compounds
- Work Surfaces including Closed- System Processing Devices

Question 8

Expiration Date versus Beyond Use Date

who determines expiration dates, based on what and when would April 2024 expire

when is BUD determined and by what 3 standards are they based on

what is the USP-NF, what is available through it and what does it include

Answer 8

Expiration Date
– Determined by manufacturer based on product stability for package insert stated conditions
■ April 2024 is April 30th, 2024

Beyond Use Date (BUD)
– After manipulation of a product
– Determined by:
■ Stability (chemical and physical) this can be affected by planned storage conditions
■ Compatibility with storage containers
■ Potential for microbial proliferation

United States Pharmacopeia – National Formulary (USP-NF)
– 5000+ standards for chemical and biologic: active pharmaceutical ingredients (APIs) and excipients
■ Monographs are available for many compounding recipes and include BUDs

Question 9

<795> Master Formulation Record

what is this considered to be

what should it include?
- do you need the name, strenght and dosage form
- do you need the materials that it is made with
- what information do you need

for BUD, what must be included
- what is needed
- what kind of instructions are needed
- what information is needed to which the examples are final product, pH, viscosity etc
- requirements on storage?

Answer 9

How the compounds are made – considered to be your recipe!

This should include:
– Name, strength, and dosage form
– Ingredients required
– Calculations and quantity required of each ingredient
– Compatibility and stability information

Beyond Use Dating
– Equipment and supplies needed
– Mixing instructions – times, amounts, temperatures, techniques
– Quality Control Information (e.g. final product description, pH, viscosity, etc.)
– Storage Requirements

Question 10

<795> Labeling Requirements

what must be included in a label

upon dispensing of the compound, additional label must include what

what may be required and based on what

Answer 10

After the compound is complete label must include:
– All active ingredients, amounts, strengths, concentrations
– Total volume of compound
– Beyond Use Date (BUD)
– Dosage form
– Storage information if other than controlled room temperature
– Internal identification number (e.g. barcode, prescription, order, or lot number)

Upon dispensing of the compound additional label must include:
– Route of administration
– Indication
– Special handling or warnings if applicable

■ Additional labeling requirements may be required based on your state laws or facility SOPs.

Question 11

what is Quality Assurance

what is Quality Control

what is the purpose of both

Answer 11

Quality Assurance
– A system that ensures the compounding process consistently meeting the quality standards.

Quality Control
– Sampling, testing, and documentation of results to show the specific parameters are met for the compound prior to its use.

Adherence to the procedure, Prevention, and detection of errors, Quality product, Follow up on adverse events or complaints

Question 12

<797> Training and Evaluation competancies

Have a
Great
Christmas & dance
Count many miracles
Always
Accept & maintain smile
Use of what
Proper what
Principles of HEPA
Proper use of PEC
Principles of movement of ____ and ____ in compounding area

Answer 12

Hand Hygiene
Garbing
Cleaning and disinfection
Calculations, measuring and mixing
Aseptic technique
Achieving and maintaining sterility
Use of equipment
Proper documentation
Principles of high-efficiency particulate air (HEPA)
Proper use of primary engineering control (PEC)
Principles of movement of materials and personnel in compounding area

Question 13

<797> Steps of Training Process
what is assessed for technique assessment
___ with what fingers
how many times is this done

what is also assessed in regards to media

what is SOP

Answer 13

USP <797>

Technique Assessment
* Garbing with fingertip and thumb sampling - done 3 times
* Aseptic with media fill (use growth media)

Standard Operating Procedures (SOP)

Question 14

<797> Personnel Preparation

Remove
- outer
- rings
- all __devices
- makeup
- nail

hand hygiene
- where should you clean under
- where should you wash up to
- how long should you scrub
- what should you dry with

hand sanitization
- what is the base of the hand rub
- what must you cover
- should they be dried partially

Answer 14

Remove
- Outer garments
- Jewelry including piercings
- All electric devices
- Cosmetics
- Artificial nails and nail polish

Hand Hygiene
- Clean underneath fingernails with a disposable cleaner.
- Wash hands and forearms up to elbows with soap and water
- scrubbing for 30 seconds minimum
- Dry hands and forearms with low-disposable towels

Hand Sanitization
- Alcohol-based hand rub
- Cover all surfaces and fingernails
- Allow to dry completely

Question 15

Garbing Order
H
F
S
H
G
H
G
70%

Answer 15

Hair Cover (head and face)
Face mask
Shoe covers
Hand hygiene
Gown
Hand Sanitization
Gloves
70% isopropyl alcohol spray

Question 16

<797> Control Engineering

what are the two types of primary control

in what situations is vertical vs horizontal air flow better

Answer 16

Primary Control
– Laminar Air Flow Workbench (LAFW)
■ Vertical and Horizontal
HEPA filters are placed to filter in air that comes into the hood

vertical works well for HD because air does not come at you

horizontal blows air toward you away from a compound that you are making

Question 17

<797> Other Types of Primary Engineering
Control (PEC)

what are the 3 other types

difference between primary and secondary control

so in total how many types of PECs are there

Answer 17

Compounding aseptic isolator (CAI)

Compounding aseptic containment isolator (CACI)

the isolators are machines where you put your compound material into and after you GARB you put your arms through and work with your compound

Biological Safety Cabinet (BSC)

difference between primary and secondary engineering control:
ante-areas and buffer areas or cleanrooms are known collectively as secondary engineering controls (SECs) because they provide the controlled environments in which PECs (laminar air flow workbenches [LAFWs], biological safety cabinets [BSCs], and compounding isolators) are placed.

types of PECs
- biological safety cabinet
- compound aseptic isolator (CAI)
- compound aseptic containment isolator (CACI)
- Laminar air flow workbench

Question 18

<797> Secondary Controls

The buffer area also houses what, what is ISO

what is the ante area, what happens in this area, what is the ISO

what ISO is the primary engineering control

Answer 18

• Buffer Area - the room where Primary Engineering Control is located, kept as clean as possible
  ISO 7 or better

Ante area - prep area before compounding, GARB up, hand hygiene
- ISO 8 or better

Primary Engineering Control is ISO 5 or better

Question 19

International Organization of Standards (ISO) Classification

where do particles come from

what are particle limits maintained through

ISO classification means

Answer 19

Particles come from:
* People
* Garments, makeup, jewelry, skin
* Paper Products
* Dust and Dirt

Particle limits are maintained through:
* Garbing procedures, no makeup, no jewelry
* Air Flow pressure settings
* Filtration – HEPA filters

number of particulates, trends down and want lowest number in primary control

Question 20

Air Flow

it is another way to control what

what do different rooms have

what is positive pressure used for

what is negative pressure used for

Answer 20

another way to control airflow entry annd the number of particulates is by using airflow

we have rooms with different pressure amounts and control what is going in and out of the spaces using compound

positive pressure:
- used in a typical non-hazardous, increased room pressure in the buffer room and pushes out into ANTE area - pushes particulates and microbes to the ANTE area

negative pressure:
- used for hazardous materials
- hood ventilation is also pulling outside and through filters away from the compounder
- assuming that it pushes air into the PEC (?)

Question 21

<797> Compounded Sterile Products (CPSs)

3 categories of compounds- denoted by the controlled environment they are compounded in

Answer 21

Category 1
- Least controlled environmental conditions
- Lowest BUD
Example:
Immediate use product

Category 2
- More environmental control and testing
- Longer BUD than Category 1
- more certain that there are no microbes growing the product
Example:
- Typical intravenous compounding in a primary control setting

Category 3
- Highest level of environmental control required and extensive testing of products
- Longer BUD than Category 1 and 2
Example:
- Higher risk compounding with products requiring lots of manipulation.

Question 22

<797> Certification of Classified Areas and PEC

what must be tested

what filter must be tested

what count must be tested

what pattern must be tested

Answer 22

Airflow Testing

HEPA Filter Integrity Testing

Total Particle Count Testing

Dynamic Airflow Smoke Pattern Testing

Question 23

<797> Microbial and Particle Monitoring

Air and Surface Monitoring
- Evaluation of results allow for what
- where should sampling of a pharmacy be done
- what must each facility have

Facilities are required to perform these tests when:
- after opening what
- after servicing what
- in response to what
- after any changes to what

Answer 23

Air and Surface Monitoring
– Evaluation of results allow for adjustment to equipment, protocols, or training
– Sampling of the pharmacy should be completed in a dynamic working environment to show real world compounding data
– Each facility must have a plan for obtaining this data and documenting the results and actions related to the results

Facilities are required to perform these tests when:
– Opening a new compounding space
– After servicing of facility or equipment
– After identified problem on previous testing
– In response to any trends that may indicate you are heading towards a problem
– After any changes are done to the compounding area, SOPs, or chemical cleaning agents

Question 24

<797> Cleaning Steps

Answer 24

Cleaning
* Contains surfactant to remove dirt and debris

disinfectant
* Destroys fungi, viruses, and bacteria

Sporicidal
* Destroys bacterial and fungal spores

minimum do these steps at least once a day

if working with level 3 organisms then do step 3 more often

Question 25

<797> Cleaning Schedule with 70% Isopropyl Alcohol after cleaning steps

Answer 25

Workbench Surface – Primary Engineering Control (PEC)
– Start of each shift
– Before each batch
– At least every 30 minutes when compounding unless your compounded product takes longer than 30 minutes than immediately after completing the product
– After spills
– Surface contamination is suspected

Question 26

<797> Cleaning Schedule

for buffer and ante rooms
what must be cleaned daily
- what is not included in this

what must be cleaned monthly
- for shelving, what must be removed and then cleaned

Answer 26

Buffer and Ante Rooms
– Daily
■ Trash
■ Floors
■ Counters
– Not including the primary control workbench

– Monthly
■ Ceilings
■ Walls
■ Storage Shelving
– Shelving – all content must be removed and then cleaned

*for high risk compounding facilities this may be done more frequently

Question 27

<797> Immediate Use Compounds

Answer 27

Definition – Low-risk preparation for immediate administration, harm to the patient if the product is delayed

■ Product can be mixed outside of the Primary Engineering Control (PEC) system
■ Must meet the criteria below to fit this category:
– Personnel are trained in USP 797 and demonstrate competency in aseptic processes
– Final product contains no more than 3 ingredients
– Administration within 4 hour
– Must have a label added to the product

Question 28

factors that are looked at when determining BUD :)
what do they consider when assigning BUD?

Answer 28

category 1
- environment

• Storage conditions (e.g. controlled room, refrigerator)

category 2
- Environment

• Storage conditions (e.g. controlled room, refrigerator)
• Compounding method
• Sterility testing is being done
• Starting compounding components (sterile vs nonsterile)

category 3
- Environment

• Storage conditions (e.g. controlled room, refrigerator)
• Compounding method
• Sterility testing is being done
• Starting compounding components (sterile vs nonsterile)

Factors that can help extend BUD (also under category 3)
- Increase the use of sporicidal disinfectants

• Increase in environmental monitoring
• Stability determination data
• Personnel training and qualifications

Question 29

<797> Master Formulation Record

Answer 29

This should include:
– Name, strength, and dosage form
– All Ingredients and characteristics if applicable
– Type and size of container closure system
– Complete instructions including equipment, supplies, description of each step and any special precautions
– Physical description of final product
– Reference source to support the stability of the CSP
– Beyond Use Date (BUD) and storage requirements
– Other information as needed (e.g. sterilization method used)

no need to memorize list

just know that there is a master form. record, additional pieces to include for 797 and not 795
– Type and size of container closure system
– Physical description of final product
– Reference source to support the stability of the CSP

Question 30

<797> Compounding Record

what should the products received include

Answer 30

When product was made, by whom, and other trackable information
■ Should include:
– Name, strength, and dosage form
– Master formulary reference
– Components
■ Name, quantity (weight or volume), strength or activity, source/manufacturer, lot number, expiration dates
– Total quantity compounded
– Identity of compounder and person completing the final check
– Date made
– Final yield (e.g. number of units, containers, etc.)
– Control number or prescription number
– Beyond Use Date (BUD) and storage requirements
– Quality control information (e.g. visual inspection, filter integrity testing, pH testing, etc.)
– Calculations made to determine quantities and/or concentrations

Question 31

<797> Labeling Requirements

After compounding is complete, what must the label include:

Upon dispensing of the compound additional label must include:

Answer 31

After compound complete label must include:
– All active ingredients, amounts, strengths, concentrations
– Total volume of compound
– Beyond Use Date (BUD)
– Dosage form
– Storage information if other than controlled room temperature
– Internal identification number (e.g. barcode, prescription, order, or lot number)

Upon dispensing of the compound additional label must include:
– Patient name and indentifiers
– Route of administration
– Administration instructions
– Special handling or warnings if applicable

Additional labeling requirements may be required based on your state laws or facility SOPs.

Question 32

USP 800

Hazardous Drug (HD) Types

what does each mean

Genotoxicity
​
■ Organ toxicity

■ Teratogenicity
​
■ Reproductive toxicity

​
■ Carcinogenicity

Answer 32

Genotoxicity
– Potential to damage DNAcan lead to cancer

■ Organ toxicity
– Potential to cause damage to an organ
at low doses

■ Teratogenicity
– Potential to fetal harm

■ Reproductive toxicity
– Potential to cause damage to the
reproductive organs

■ Carcinogenicity
– Potential to cause cancer

Question 33

<800> Receiving

after receiving, HDs should be
- visibly inspect for what
- separated from what
- unpackaged and immediately placed where
- what should be worn when opening and removing content from packages

Answer 33

HDs should be
– Visibly inspected for damage
– Separated from other medications
– Unpackaged and immediately placed in a HD storage area
– Appropriate personal protective equipment should be worn when opening and removing content from packages

Question 34

<800> Storage

should HDs be assessed? If so, for.what
- how should HDs that require manipulation be stored
- how should HDs that are single dose packaged and do not required manipulation be stored

should HDs be stored in way that prevents spills, leaks or breakage if container falls? If so, where must they not be stored on
- what are a good option for shelving

Answer 34

HDs should be:
– Assessed for risk
■ HD that require manipulation should be stored away from other drugs
■ HD that are single dose packaged and do not require manipulation can be stored with non-HDs

– Stored in a way that prevents spills, leaks, or breakage if the container falls
■ They can not be stored on the floor.
■ Shelving with raised lips on the front are a good option

Question 35

<800> Compounding
-what should compounding persons wear that includes what

• what does american society for testing and materials have

what should be worn if there is a risk of dust or debris

what there is concern of vaporization of med. what is required

– Negative pressure technique for ___ compounding should be used or a ____ system ____ device (CSTD) should be used to prevent ____ of HD

Answer 35

Persons compounding HD:
– Should wear personal protective equipment (PPE) including a chemotherapy gown, two pairs of shoe covers, and two sets of chemotherapy gloves

American Society for Testing and Materials (ASTM) – standards for chemotherapy designation

If there is a risk of dust or debris a N95 mask is required

If there is concern about the vaporization of medication a respirator is required

– Negative pressure technique for IV compounding should be used or a closed system transfer device (CSTD) should be used to prevent contamination of HD - aseptic technique

Question 36

<800> Compounding Area Requirements

where should an HD sterile preparation be done

what does ISO 7 maintain

where should an HD non-sterile preparation be done to prevent the spread of HD

Answer 36

HD Sterile Preparation:
– In a negative pressure area to prevent the spread of hazardous materials
– Ante Room

Required to be ISO Class 7 – this to maintain the negative pressure environment to prevent the spread of HD particles

HD Nonsterile Preparations:
– Containment ventilated enclosure or biological safety cabinet need to be used to prevent the spread of HD
■ This is different than non-HD
■ Required to be ISO Class 5

Question 37

<800> Dispensing

how should All HD be:
- labeled stating what
- labeled for antineoplastics

IV ports be sealed to provide what and prevent what

Answer 37

All HD should be:
– Labeled stating “Caution: Hazardous Drug”
– All antineoplastics (chemotherapy agents) should be labeled with “Chemotherapy – Dispose of Properly”
– IV ports can be sealed to provide a physical barrier and prevent leakage

Question 38

<800> Administration

Answer 38

Administrator should:
– Wear proper PPE
■ All antineoplastics require two pairs of chemotherapy gloves
– If an injectable this also requires a chemotherapy gown
– Single pair of glove is acceptable if it is a intact tablet or capsule
■ Single pair of gloves should be worn for other types of HD

Question 39

<800> Disposal

all PPE worn is considered to be what

what cannot be discarded in regular trash

Answer 39

Yellow Disposal Bins – Trace HD
– All PPE worn during compounding is considered contaminated
■ Inner gloves and inner shoe covers are not and can be discarded in the regular trash
– Empty vials, syringes, IV bags, IV tubes

■ Black Disposal Bins – Bulk HD
– Unused or partially empty vials, syringes, IV bags

Question 40

<800> Sanitization

what do you use for Deactivation/Decontamination
what does it do

what do you use for cleaning
what does it do

what do you use for disinfection
what does it do

Answer 40

Deactivation/Decontamination
*2% sterile bleach or peroxide
*Reduces toxicity and removes HD residue
- break down the chemical structure

Cleaning
*Germicidal Detergent
*Removes dirt and microbe contamination

Disinfection
*70% Sterile Isopropyl alcohol (IPA)
*Inhibits or destroys microbes.

Question 41

<800> Training Requirements

Prior to the start of the position and then at least annually (every 12 months) what must occur
- prior to what
- is it for old or new equipment being used
- what must be obtained for all workers and what must it acknowledge

Answer 41

Prior to the start of the position and then at least annually (every 12 months)
– Additional training should occur:
■ Prior to new protocols or processes going into effect
■ New equipment being used

■ A consent form for all workers should be obtained acknowledging the risks of handling HD.

Question 42

USP 797

Air Exposure Time In and Out of PEC

opening vials and maybe we do not use all of it, so if we open it how long is it good for or is there a time frame

different types of products

Answer 42

Ampule - if you open it, use it immediately
Inside ISO 5 PEC & Outside ISO 5 PEC
- Immediate use only

Single-dose vial
Inside ISO 5 PEC: 12 hours
Outside ISO 5 PEC: 0 seconds

Pharmacy bulk package
Inside ISO 5 PEC: 12 hours
Outside ISO 5 PEC: 0 seconds

Multi-dose vial - has antimicrobial agents
Inside ISO 5 PEC: 28 days
Outside ISO 5 PEC: 28 days

Each medication should be checked with the package insert at the manufacturer’s directions. Some medications may have a shorter timeframe.

Multi-dose vials have preservatives in them allowing for an extended time.

Question 43

Aw

Answer 43

water activity

Question 44

*Master Formulation Record

Answer 44

Recipe to make the compound

Question 45

*Compounding Record –

Answer 45

Record of making the product