Compounding Flashcards
Compounds you cannot make:
-drug removed from market by FDA because component unsafe
-large amounts of drug that are copies of commercial products (but can be for individual patient if there is change to it slightly or if product temp unavail)
-large amounts of drug in cases where there is no historical pattern (would constitute as manufacturing)
A pharmacy must have a person designated to be responsible for implementation of compounding procedures (non-sterile, sterile, or hazardous). True or false
True-could be the same person for all 3 if necessary; does not have to be a pharmacist
Opthalmic and inhalation suspensions do not need to be sterile. True or false
False!
Hazardous drug compounding can be sterile or non sterile. True or false
True
Compounded drugs are subject to GMP?
No-they are not FDA approved drugs
Non-sterile compounding frequency of competency?
Initially and then every 12 months
What garb is required for non-sterile compounding?
Gloves. Change or wipe gloves when starting new procedure. Gowns not required but can be reused
For non sterile products-how often does temp need to be monitored?
Daily
Does non sterile compounding require its own room?
No-should have its own designated area.
What is required before something is compounded for the first time?
Master Formulation record; then a compounding record must be completed each time it occurs
What must be included in a master formulation?
-name/strength/dosage form
-calculations needed
-compatibility/stability
-mixing
-sample labeling with BUD guidance
-container for dispensing
Every non sterile compound requires a label saying what
“This is a compounded preparation”
What must be included in a compound record?
name/strength/dosage
MFR used
info of components (source/lot/exp)
total quantity prepared
name of person who prepared
name of person with quality control
date of prep
Rx number
BUD
Who often do you need to undergo media fill tests for category 1 and 2 preparations?
every 6 months
Who often do you need to undergo media fill/garbing tests for category 3 preparations?
every 3 months
What must be applied to gloves before sterile compounding?
70% IPA
What circumstances may be gown be reworn in sterile compounding?
-gown maintained in classified area to prevent contamination
-class 1 and 2 compounding
remember everything else must be discarded
Category 3 compounding garb rules”
-no exposed skin; face or neck must be covered
-all low lint outer garb must be sterile
-disposable garb can’t be reused
A drug infusion can finish after BUD date. True or false
True-it must just be started before BUD date
When must a single use container be used in ISO5 air?
12 hours
How long is BUD for multi dose vial?
28 days
Category 1 CSP
-can be prepped in unclassified segregated compounding area
-BUD </= 12 hrs room temp and </= 24 hours refrigerated
Immediate use CSPs are exempt from garbing and ISO5 as long as:
-no more than 3 different sterile products
-administration is within 4 hours of start of prep
-cannot be stored/prepped in advance
Category 2 CSP
-must be in a cleanroom suite
-BUD >12 hrs room temp and >24 hrs refrigerated
Category 3
-BUDs up to 180 days
ISO Class air in ante room?
7/8
ISO Class air in hood?
5
How often must Primary Engineering Control (Hood?) be cleaned?
-beginning of each shift
-before each batch
-not longer than every 30 minutes when compounding is ongoing
-floors and countertops: daily
-walls/ceilings/storage: monthly
Master formulation records must be created for any CSP prepared for more than 1 patient. True or false.
True
What is limit for field units for CSP sterility testing (??)
250 final yield units
How quickly must single dose vial be used?
12 hrs
Hazardous PPE expectations
-cannot reuse disposable PPE
-gowns, head, hair, shoe covers, and two pairs of chemo gloves required for preparation and administration
How often must chemotherapy gloves be changed?
every 30 minutes
How often must HD gowns be changed?
-every 2 to 3 hours or immediately after splash
2nd pair of shoe covers must be donned before entering HD areas. True or false
True
What type of mask needed for HD prep?
N95
Sterile and nonsterile HD can be stored together. True or false
true-but HD used for nonsterile compounding should not be stored in areas designated for sterile compounding to minimize traffic to that area
Pharmacy can compound drugs w/o Rx if its an anticipation of typical Rx. What is required for documentation?
-name/strength vs list of active ingredients
-pharmacy assigned control number
-BUD
-quantity
Who must obtain outsourcing license?
-Sterile compounding of drugs to be dispensed without a prescription
-reminder: must have PIC
-records are for 5 years
What is required for 795 training?
-every 12 months competency
-understand 795
-understand/interpret safety data sheets
-understand procedures related to compounding duties
How often does NSCP vent need to be recertified?
Every 12 months
How often must NSCP be sanitized and cleaned?
-sanitized: daily and if compounding not performed daily, before initiating compounding
-cleaning: beginning and end of each shift
How often does biosafety cabinet need to cleaned/sanitized for NSCP?
-beginning of each shift when compounding occurs, after spills, surface contamination
-between compounds w different components
-under the work surface monthly
What must be done if CSP is not going to be dispensed on the day that it was prepared?
A visual inspection must be done prior to dispensing to make sure no precipitation
**This excludes dispensing to Pyxis (by law this is the same as dispensing to patient, RN should inspect)
When can distilled water be used for compounding ?
-non sterile
-rinsing equipment
-IF the water meets the requirement of purified water you can use it to compound
When making hazardous drugs when do gown and outer pair of shoe covers need to be removed?
Doffing area PRIOR to leaving negative pressure room
When making hazardous drugs when must gloves be removed?
Inside the C-PEC. All other items besides gown and shoe covers can be removed in anteroom
How soon must water containing CSPs that are nonsterile during any phase of compounding procedure be sterilized?
within 6 hours after completing the preparation in order to minimize the generation of bacterial endotoxins.
Manufacturers must comply with 797. True or false
False-they must comply with CGMP
A master formulation record is required for repackaging conventionally manufactured components. True or false
True-MFR is required if you are making CSP for more than 1 patient or for CSPs that are prepped from nonsterile ingredients
Pharmacists can distribute compounded drug products for subsequent distribution/sale to other persons or commercial entities. True or false?
False-this can only happen to vets (vet cannot dispense more than 7 day supply)
-another scenario is if there is a critical need/emergency condition (remember bc this is not in context of patient/prescriber relationship)
Pharmacists may compound without RX to vet. True or false
True-limit to drugs necessary to treat an emergent condition
When must you have individual hazardous drug equipment?
Mortars and pestles, anything disposable, equipment that comes in direct contact with HD.
Anything that doesn’t come in direct contact can be multipurpose but must be deactivated/decontaminated
Who is not required to do media fill tests with CSP?
People who only do immediate use CSP
When do you NOT need to test nonpreservative topical opthalmic CSP for anti microbial effectiveness ?
-prepped as cat 2 or 3
-for single patient use
-must be discarded within 24 hr of opening room temp or 72 hr room temp
Does pharmacist need to recheck compounded product visual inspection if in ‘pick up area’?
No-not if only awaiting pick up or delivery
Biosafety cabinets can be used for what type of compounding
Non sterile (HD or non HD)
(Protects personnel but not product)
Personnel who only do immediate use CSP must do media fill testing
False-must do others though
