Ch 5: Compounding Flashcards
FED Select all. Compounded drugs should be: A) Based on a prescription B) FDA-approved C) Commercially available D) Follow USP standards
A, D
Compounded drugs are NOT commercially available, and are made for an individual pt based on a prescription, and are not FDA-approved
FED Who sets the standards for compounding preparations
USP
FED The 2012 contamination issue located at the ____ that was responsible for an outbreak of ____ caused a subsequent change to legislation involving the FDCA
New England Compounding Center
Fungal meningitis
FED The fungal meningitis outbreak at NECC resulted in the development of what piece of legislation
The Drug Quality and Security Act, which was an alteration to the FDCA
FED The DQSA breaks down sections 503A into ___ and 503B into ___
503A = traditional compounding 503B = outsourcing facilities
FED Preparing an IV and making magic mouthwash is likely pursuant to
A) 503A
B) 503B
503A = traditional compounding
FED Compounding medication for bulk office use is likely pursuant to:
A) 503A
B) 503B
B) 503B = outsourcing facilities
FED Select all. Which of the following follow both USP and CGMPs?
A) 503A
B) 503B
C) Manufacturing
503B and manufacturing, but 503A does NOT follow CGMPs
FED Compounding for bulk medical office use is prohibited under which, 503A or 503B
503A
FED A provider stocks a professionally compounded medication for office use. Where did he likely source these from?
A) A traditional compounding facility
B) An outsourcing facility
B) outsourcing facility
FED Who regulates a 503A pharmacy vs a 503B pharmacy
503A = State boards 503B = FDA, state license may be required
FED Select all. Which requires registration with the FDA?
A) Drug manufacturer
B) 503A traditional compounding facility
C) 503B outsourcing compounding facility
Drug manufacturer & 503B outsourcing facility
FED Which of the following is likely to require a patient-specific prescription prior to preparing a drug product?
A) 503A facility
B) 503B facility
C) Drug manufacturer
A–503A pharmacies provide traditional compounding based on patient-specific prescriptions
FED T/F Physicians and other healthcare practitioners are permitted by federal law to compound in medical offices
True
API abbreviation means
active pharmaceutical ingredients
FED Ingredients that are acceptable for use in compounding will be listed:
A) In the USP National Formulary (USP-NF)
B) In the Food Chemicals Codex (FCC)
C) In either A or B
D) In both A & B
C = either the USP-NF or the Food Chemicals Codex
FED Under what circumstances can a compounding ingredient that is not manufactured at an FDA-registered facility be used to compound?
A) Always, there is no FDA requirement for ingredients since compounding products are not FDA approved
B) If a Certificate of Analysis (CoA) is obtained to confirm quality
C) So as long as the ingredients are both USP-NF approved and FCC approved
B = it is preferable for ingredients to be manufactured at an FDA-registered facility, if not, a CoA should be obtained to confirm the quality
FED If there is no expiration date on a compounding ingredient upon receipt, what should the pharmacist do?
A) Label it to be 1 year from date of receipt
B) Label it to be 3 years from the date of receipt
C) Send the product back to the supplier
B: if component without expiration date, RPh assigns a conservative date that is no more than 3 years from the date of receipt
FED If a pharmacist assigns an expiration date to a compounding ingredient, what should the label include? A) The date of receipt B) Assigned expiration date C) NDC D) Both A&B E) All of the above
If RPh assigns the expiration to a compounding ingredient, it should be no later than 3 years from date of receipt, and label should have the expiration date and the date of receipt
FED A compounded preparation for a per rectum medication is considered to be:
A) Sterile
B) Nonsterile
Nonsterile
FED Select all. Per USP 795, nonsterile compounding may:
A) Be prepped in a distinctly separate location from sterile preps
B) Be performed in a PEC at minimum
C) Be performed in ambient/room air
D) Be separated from the dispensing part of the pharmacy
A) True: separate location from sterile preps
B) False, can be done in room air
C) True, can be done in room air
D) True, should be separated from dispensing part of the pharmacy
FED A technician comes upon compounding supplies, tools, and excipients stored on the floor. Is this of concern?
A) If they are for non-sterile compounding, no
B) If they are for sterile compounding, this is wrong
C) Pharmaceutical ingredients for compounding should not be stored on the floor, but the supplies are fine
D) No compounding components are to be stored on the floor for compounding of any sort
D = no compounding components (drugs, excipients, equipment, containers) are to be stored on the floor for any type of compounding
FED A tech has compounded a nonsterile, oral formulation that contains water. What is the BUD and storing temp?
Nonsterile, water, oral = fridge, 14 days BUD
FED An RPh compounded a nonsterile, oral formulation that does not contain water. What is the BUD and storing temp?
Nonsterile, no water = room temp 6 months
FED An RPh compounded a nonsterile, non-oral formulation that contains water. What is the BUD and storing temp?
Room temp, 30 days
FED A tech compounded a nonsterile non-oral prescription that contains poloxamer gel. What is the BUD and storing temp? A) Fridge, 14 days B) Fridge, 30 days C) Room temp, 14 days D) Room temp, 30 days
D. Poloxamer gel contains water. Non oral = room temp, 30 days
FED T/F The BUD of a nonsterile compounded prep can be extended if stability data is obtained that shows a longer stability period
True. I’m not sure if this applies to sterile or not
FED Select all. Which of the following would likely be considered sterile preps if compounded? A) IV B) Oral C) Bladder irrigation D) Rectal suppository E) Nasal inhalations
A) IV = sterile B) oral = nonsterile C) bladder irrigation = sterile D) Rectal supp = nonsterile E) Nasal inhalation = nonsterile (but pulmonary inhalations ARE sterile)
FED When compounding in critical areas closest to exposed sterile drugs, the air should be at least ISO
5 or LESS…. meaning ISO 4 is fine, but ISO 6 is not
FED According to ISO ratings, ambient or room air is considered: A) ISO 10 B) ISO 8 C) ISO 7 D) ISO 6 E) Unclassified; not rated
E, ambient room air is not ISO rated
FED If using a PEC for sterile compounding, the space should also include:
A) A SEC
B) An anteroom
C) All of the above
C. Should be anteroom + SEC + PEC…… or CAI + SCA
FED Which of the following are acceptable for a sterile compounding space? A) Anteroom + SEC + PEC B) Garb room + anteroom + SEC + PEC C) CAI + SCA D) A&C E) All of the above
D.
Anteroom + SEC + PEC, or
CAI + SCA
FED What might a CAI also be called
Glove box
FED What might the SEC also be referred to as
Buffer area. NOT the anteroom
FED What purpose does the anteroom serve
A) Provide a buffer of relatively clean air around the PEC or PECs
B) Comprises a separate area for hazardous compounding
C) Connects the rest of the pharmacy to the SEC to provide a place for garbing
C
FED Garbing and handwashing take place: A) Before entering the anteroom B) In the anteroom C) Before entering the buffer area D) In the buffer area
B, garding and handwashing takes place in the anteroom, prior to entering the SEC (SEC = buffer area)
FED The buffer area, or SEC, should be at least ISO
7
FED The anteroom should be at least ISO __ for nonhazardous sterile compounding, or ISO ___ for hazardous sterile compounding
ISO 8 for pos pres non-HD
ISO 7 for neg pres HD
FED If performing sterile compounding in a CAI located in an SCA, the ISO rating of the SCA should be classified as: A) ISO 5 B) ISO 7 C) ISO 8 D) Is it not classified
A segregated compounding area is a separate area, the air in an SCA is not classified according to ISO standards
FED Hazardous compounding shouldn’t be done in an area with __ air pressure
Positive…. HDs need negative air pressure
FED Which type of STERILE compounding uses NON-sterile ingredients or equipment that must be sterilized prior to use?
A) Low risk
B) Medium risk
C) High risk
C) High risk. High risk sterile compounding is not common
FED Fill in the following ISO requirements: PEC = ISO \_\_\_ SEC = ISO \_\_\_ Anteroom, HDs = ISO \_\_\_ Anteroom, non-HDs = ISO \_\_\_
PEC = 5
SEC = 7
Anteroom, HD = 7
Anteroom, non-HD = 8
FED Reconstituting a 1g single-dose vial of cefazolin with sterile water and transferring it to a normal saline bag is considered
A) Low risk
B) Medium risk
C) High risk
Low risk, because there are no more than 2 entries into any 1 sterile container/device, and = 3 sterile ingredients including diluent
FED Low risk sterile compounding is considered to be done when there are ____ ingredients including diluent, and no more than ___ entries into any ___ sterile container(s)/device(s)
Low risk sterile compounding = 3 or fewer sterile ingredients including diluent, no more than 2 entries into any 1 sterile container/device
FED Medium risk sterile compounding is considered to be done when ___ sterile ingredients, OR ___ doses of a sterile product are withdrawn from the same vial
Medium risk sterile compounding = greater than 3 sterile ingredients, OR multiple doses of a sterile product withdrawn from same vial to make several CSPs batches
FED Sterile compounding products that are made from nonsterile equipment and ingredients, then sterilized prior to use are considered:
A) Low risk
B) Med risk
C) High risk
C, high risk
FED What are the room temp, fridge, and frozen BUDs for a low risk CSP
Low risk CSP = 48H room temp, 14D fridge, 45 days frozen
Low/med/high are all 45D frozen
FED What are the room temp, fridge, and frozen BUDs for a medium risk CSP
Med risk CSP = 30H room temp, 9D fridge, 45D frozen
FED What are the room temp, fridge, and frozen BUDs for a high risk CSP
High risk CSP = 24H room temp, 3D fridge, 45D frozen
FED How long is IV Bactrim stable for once diluted, window of time
2-6 hours, so the BUD is 2-6 hours depending on the final concentration
FED What are 2 examples of ISO 5 PECs that can be used inside of an SCA
LAFW or CAI. CAI is aka glovebox
FED Low risk CSPs prepared in an ISO 5 PEC in an SCA receive a BUD of ___ for room temp and ___ for fridge and ___ for freezer
Since its made in an ISO 5 PEC in SCA area, the BUD for fridge/room temp is 12H for both, and is NOT to be frozen
FED Immediate-use CSPs should be at what temperature and administration should have started within what time frame
Room temp, start administration w/i 1 hour
FED What 3 parts of aseptic technique are evaluated during a gloved fingertip test
Hand hygiene, garbing, and gloving
FED How often is passing the gloved fingertip test when compounding low, medium, and high risk CSPs initially and then afterward
low/med risk = initially, then annually
high risk = initially, then semi-annually
FED During an INITIAL gloved fingertip test what is considered passing
Three consecutive gloved fingertip samples taken after garbing with ZERO CFUs for both hands
FED During an ongoing competency exam gloved fingertip test, what are the requirements to pass
At least one sample taken after the completion of the media-fill test, with a goal of = 3 CFUs
FED A failing score on the media-fill test is indicated by ___ in the bag after a period of ___
Turbidity (cloudiness) in the bag after 14 days of incubation is a failing media-fill test
FED What temp should the SEC be kept at, and how many times a day should it be monitored and logged in the log sheet
68F or cooler, SEC monitored at least once daily
FED The fridge and freezer should be monitored ___, and if they contain vaccines, ____
Fridge freezer, monitor daily, unless they have vaccines, then twice daily
FED What is the proper fridge and freezer temp ranges
Fridge = 2-8C Freezer = -25 to -10 C
FED Air sampling should be done how often
At least every 6 months by a person certified in air sampling, or by a qualified compounding staff member
FED USP requires that surfaces be tested how often? And what time of day should they be tested
“Periodically”….. testing should occur at the end of the day when the surfaces are in the poorest state
FED When performing surface sampling, what areas should the samples be taken from
Each from the different ISO areas…. so at least one each from ISO 5, 7, and 8 area
FED Air pressure testing involves identifying if a correct differential is present… what does this ensure
Ensures the airflow is unidirectional
FED How often are air pressure gauges checked
At least once daily or with every work shift
FED What should the humidity be, and how often should it be checked
Humidity not to exceed 60% and at least once daily
FED Order the garbing sequence to take place in the anteroom: gown, handwashing, head/face covers, shoe covers
Head/face covers
Shoe covers
Handwashing
Non-shedding gown
FED Order the garbing sequence to take place in the buffer room (SEC): gloves, sanitize gloves with 70% IPA, alcohol-based hand scrub
Alcohol-based hand scrub (povidone/chlorhexidine)
Sterile, powder-free gloves
Sanitize gloves with 70% IPA
FED What place determines which drugs are hazardous
NIOSH
Name 4 common transplant drugs on the NIOSH list of HDs
cyclosporine, mycophenolate, tacrolimus, sirolimus
FED SDS (formerly MSDS) are safety documents required by ___ to be accessible to all employees working with hazardous materials, including HDs
OSHA
FED When working with HDs, each pharmacy should have a designated individual who creates SOPs for the steps of working with HDs, which is called the
hazard communication program
FED Pharmacies must keep a list of all HDs stocked, to be reviewed every ___, or whenever ____
Reviewed every 12 months, or whenever a new drug/dosage form is stocked
FED If a C-SEC is being used for non-sterile HD compounding, it hsould keep an ISO of at least
7
FED If using a C-PEC for sterile HD compounding, and there is another C-PEC in the room, how far apart should they be? What activity cannot be done during this time?
At least 1 meter apart, and no particle-generating activity (working w powders) can be performed while sterile compounding takes place (I think just with HDs?) pg 99
FED For HDs, what are the exhaust requirements for sterile vs nonsterile HD compounding
Sterile HD = externally VENTED through HEPA with >/= 30 ACPH
Nonsterile HD = externally EXHAUSTED or passed through at least 2 HEPA filters in a series (redundant HEPA filter) with >/= 12 ACPH
FED Compounding of all HDs should be done with ___ air pressure
negative
FED Closed-system transfer devices (CSTDs) are ___ when compounding HDs, and ____ when administering antineoplastics
Recommended when compounding HDs, required when administering antineoplastics if available
FED To avoid the time and expense of following all USP 800 requirements, a pharmacy may conduct an ___. This document should be reviewed at least ___
Assessment of Risk (AoR) for HD drugs w lower risk…. document should be reviewed at least every 12 months
FED As part of developing an Assessment of Risk for HDs, the pharmacy must develop ____ to limit staff exposure
SOPs
FED Select all. Which of the following would a C-PEC have to be used for when handling HDs? A) Counting tablets B) Packaging tablets C) Cutting tablets in half D) Using powder to prepare a solution
C and D, pg 101
FED How many pairs of chemo-rated gloves are necessary for each of the following:
A) Compounding
B) Cleaning spills
C) Receiving/storage
Compounding & cleaning = 2 pairs
Receiving & storage = 1 pair
FED Gowns for preparing and administering HDs and spill clean-up should be ____ and _____
Disposable, and impermeable to spills
FED Head, hair, and shoe covers should be worn while prepping sterile and non-sterile HDs, but two pairs of ___ should be worn when compounding sterile HDs
Two pairs of shoe covers when compounding sterile HDs… but I guess not for nonsterile pg 101
FED Eye and face protection should be worn when there is a risk for HD ___
spills or splashes….. for fucks sake
FED Respiratory protection for most HD compounding includes ____, unless it involves _____
N95 respirator, unless it involves gases, vapors, or liquid splashes
FED Who regulates the proper disposal of HDs
The EPA
FED Bulk antineoplastic waste goes in the ___ container, and trace antineoplastic waste goes in the ___ container
Bulk = BLACK Trace = Yellow
FED All PPE worn when handling HDs is considered contaminated with ___ waste
trace waste
FED Shipments containing HDs should be:
A) Unpacked normally
B) Unpacked wearing chemotherapy gloves
C) Unpacked wearing appropriate PPE, including pair of chemotherapy gloves
C
FED When HDs are unpacked and not contained in plastic, the staff member should wear an elastomeric half-mask with a multi-gas cartridge and P100-filter, at least until ____
assessment of the packing integrity ensures that no breakage or spillage ocured during transport
FED A spill kit should be available near the designated receiving area when unpacking ___
HDs
FED Select all. How should HDs be stored?
A) On the floor
B) Off the floor
C) Separate from non-HDs
D) In a negative pressure room
E) External ventilation and at least 12 ACPH
B, C, D, E
FED If a delivery containing HDs is damaged, it must be placed in a sealed container, labeled as hazardous, and placed ____ until it can be returned or disposed of
A) In a negative pressure room
B) In the C-PEC if possible, if not, a negative pressure room
B
FED Pneumatic tubes should not be used to transport any ____ HD or ____ agent
liquid HD, antineoplastic
FED How many pairs chemo gloves when administering HDs
Two pairs
FED Select all. How to administer IV HD drugs A) 2 pairs chemo gloves B) Non-shedding gown C) Chemo gown D) CSTD, if available
A, C, D
FED If administration of an oral HD includes manipulation such as crushing tablets, it should be done in a
Plastic bag… I would have thought the hood, pg 103
FED Select all. Pharmacies doing HD compounding must perform wipe sampling of all compounding surfaces: A) Initially B) Every 6 months C) Every year D) Every 2 years
Initially + every 6 months
FED Select all. Personnel handling HDs should receive training: A) Initially before handling any HDs B) Every 12 months C) Every 3 years D) When a new HD/equipment is involved
A) True, initially
B) True, every 12 months
C) False, not every 3 years
D) True, when a new HD/equipment comes in
FED ____ protection must be worn when there is a risk for spills or splashes involving HDs, including when working inside of ____
Eye/face protection must be worn when ther is a risk for spills or splashes with HDs, including when working in a CPEC and outside a CPEC
FED Respiratory protection for most HD compounding
N95 respirator
FED T/F An N95 supplies sufficient protection agains gases, vapors, or direct liquid splashes from HDs if both NIOSH and OSHA rated
False
FED Select all. If there is a risk of respiratory exposure to HDs, which of the following may be worn:
A) Level 3 surgical mask
B) N95 respirator
C) Fit-tested respiratory with gas canisters
D) PAPR
C & D
FED N95 respirator, HD waste bag, chemo pads, and goggles with side shields are likely components contained within:
A) An HD-unloading basket
B) An HD spill kit
B
FED T/F An HD spill report exposure form does not need to be filled out if the exposure was only for a single person
False, an HD spill report exposure form needs to be used to document each time an HD exposure happens from a spill
FED A pharmacy may compound a prep with II-V drugs if it does not contain more than ___% controlled substances
20%
FED What are the 2 records that each compounded product must have
1) Master formula record = recipe
2) compounding log/record = log of all products made
FED Select all. The master formula is likely to contain: A) Equipment needed B) Calculations C) Recommended BUD D) QC results E) Lot numbers & expiration dates
A, B, C…. D&E are compounding record/log
FED Select all. The compounding log is likely to contain: A) Preparation/mixing instructions B) Recommended BUD C) QC results D) Staff involved w prep E) Steps followed
A) Prep/mix instructions: no B) Recommended BUD: no, should be actual BUD C) QC, yes D) staff, yes E) steps followed, yes pg 105
FED USP 795 recommends, and section 503B federal regulations require, the following statement or similar on the label of a compounded product:
A) “Made for the above labeled individual only”
B) “This is a compounded drug”
C) “This product is not FDA-approved”
B) “This is a compounded drug” or similar
FED Select all. Endotoxins are produced by:
A) Particulate matter from aersolization of HDs
B) Gram-neg bacteria
C) Gram-pos bacteria
D) Fungi
B, C, D
FED Endotoxins from _____ represent a serious threat to patient safety, therefore certain CSPs must test negative for ____ before use
Gram-negative bacteria; pyrogens
FED Finished CSPs should be inspected against ___ immediately after prep to check for particulates, cored pieces, preciptates, and cloudiness
A) A dark background
B) A light background
C) A UV-light
A, a dark background
FED If a drug is to be repackaged, such as for a unit-dose pack, the USP and FDA guidance assigns a BUD of
Six months from date of repacking, unless the manufacturer says it expires sooner
