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37 Cards in this Set
- Front
- Back
What is a compounded sterile preparation (CSP)?
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Any compounded:
Biologic, diagnostic, drug, nutrients, radiopharmaceutical |
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What is the justification for 797?
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USP Chapter 797 evolved over a number of years as a means of addressing compounding practices as sources of infections
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Which 797 chapters are enforceable by the FDA?
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General chapters numbered <1> to <999>
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What 797 chapter are not enforceable?
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General chapters <1000> to <1999> are considered informational and not enforceable
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Which 797 chapters pertain to nutritional substances?
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Chapters greater than <2000>
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True or False
The least expensive changes by USP <797> typically tend to be the most effective in reducing CSP contamination and inaccuracy |
True
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What are the exceptions to the <797> risk level assessment?
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Immediate Use and Low Risk with <12 hr or less BUDs
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Describe the compounding techniques and requirements for Low-Risk Level drugs
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- All are compounded using aseptic techniques using sterile ingredients
- Limited to using not more than 3 commercially manufactured products - Manipulations with low risk CSP's are limited opening, penetrating stoppers, transferring and packaging for storage and dispensing |
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BUD for Low Risk Level
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48 hours (at room temperature)
14 days (refrigerated) 45 days (frozen) |
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Low Risk Level with <12 hour BUD
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-to accommodate satellite pharmacies compounding only low risk level CSPs
-compounding of hazardous drugs are not permitted -low risk level CSPs do not require the ISO class 7 clean room or buffer area and only require an ISO class 5 hood -Area needs to be segregated from other parts of the pharmacy and designated for use as a compounding area -personnel shall follow cleaning and garbing requirements -sings should not be placed adjacent to the ISO class 5 hood |
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Medium Risk level
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-utilized in bulk quanitites
-aseptic manipulations using only sterile ingredients -intended for multiple patients or for one patient for multiple occasions -more complex than low risk compounding -may require unusually long duration such as that require to complete dissolution or homogenous mixing -no bacteriostat and administered over several days |
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BUD Medium Risk level
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30 hours (room temperature)
9 days (refrigerated) 45 days (frozen) |
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High risk Level
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-prepared from non-sterile ingredients
-these CSPs are either contaminated or at high risk for being contaminated -sterilization occurs after compounding -if the components is assumed but not verified by documentation such as with bulk ingredients where a certificate of analysis is available |
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Examples of High Risk Level
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-Compounding using non-sterile water that will not be sterilized within 6 hours of being compounded
-sterile ingredients that are exposed to air quality that is worse than ISO class 5 for more than 1 hour -CSPs compounded (or exposed to) personnel that are not properly garbed and gloved |
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BUD High risk level
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24 hours (room temp)
3 days (refrigeration) 45 days (frozen) |
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Immediate use category
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-Immediate use compounds are exempt from ALL requirements in <797> and is intended for situations where there is a need for emergency or immediate patient administration (examples include: cardiopulmonary resuscitation, emergency room treatment, preparation of diagnostic agents)
-the intent is that once compounding begins that there are no delays or interruptions of the process all the way to administration to the patient -the dose must be discarded if the administration has not begun within 1 hour, the dose must be labeled if not administered by the preparer |
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Low Risk CPCs that qualify for immediate use category
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-only simple aseptic measuring and transfer are needed
-only non-hazardous products or diagnostic radiopharmaceutical products are used -not more than two entries into any one container or package prepared -aseptic is followed during preparation -administration begins within 1 hour of the start or preparation |
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Low risk 12 hour BUD
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12 hour (room temperature)
12 hour (refrigeration) |
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Immediate use BUD
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1 hour (room temperature)
1 hour (room temperature) |
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What are the facility design requirements?
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-must have an ISO class 5 environment as a PEC for critical site exposure. Laminar airflow workbenches, BSCs, CAIs, and CACIs are common ISO class 5 environments
-The compounding area must be separate from activities not essential to CSP preparation and must be a controlled particle (particle, temperature) environment -Must have an ISO class 7 environment for buffer area or cleanroom -must have an ISO class 8 environment for anteareas -Buffer areas physically separated from ante areas must have a positive pressure differential; if no physical separation is present displacement airflow principles be used (high airflow velocity, low pressure differential) -high risk compounding is not eligible for displacement airflow, a physical separation must exist between buffer room and anteroom -Must have adequate ACPHs to maintain appropriate ISO class, ACPH May be improved upon by PECs that recirculate air between the room and the PEC itself |
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Three primary environmental areas are:
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Direct Compounding Area (cleanest)
Primary engineering control (PEC) (clean) Buffer Area and the Ante Area (dirty) The rest of the pharmacy (dirtiest) |
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Environmental and engineering controls
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Placement of non-essential items within buffer and ante areas is determined by the impact on environmental quality as verified by monitoring
PECs must be physically located within an ISO class 7 buffers |
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Environmental testing
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Environmental monitoring must be routinely performed to prove that the compounding environment is properly maintained
-documentation that proves control is required -must conduct regular surface sampling to test for adherence to cleaning and disinfecting procedures |
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Cleaning procedures
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-there must be detailed cleaning and sanitizing procedures for ISO class 5 PECs in or to maintain the cleanliness of the direct compounding area
-buffer area and ante area ceilings , walls, and shelving must be cleaned monthly, while counters, work surfaces, and floors must be cleaned daily -Visual observation of cleaning and disinfecting techniques for all compounding and non-compounding personnel must occur specified intervals |
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Prior to entering buffer area or segregated compounding area
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Remove all personal outer garments
-remove cosmetics -remove jewelry from hands, wrists, or any other visible body parts -no artificial nails allowed -Don PPE in the following: 1. dedicated shoes or shoes covers 2. head and facial covers 3. face masks/eye shield 4. perform hand cleansing procedures 5. non-shedding gown |
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What do you do upon entering buffer area or segregated compounding area?
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1) Antiseptic hand cleansing with surgical scrub
2) Don sterile powder-free gloves |
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Personnel training and competency testing
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In addition to media fill testing, subjects matter areas of garbing, aseptic technique, achieving and maintaining various ISO class conditions and cleaning and disinfection techniques must be included in training procedures and competency evaluations
-gloved fingertip sampling and witnessed handwashing and garbing for all compounding personnel competency assessments -competencies, didactic training, written examinations, media fill testing, and gloved fingertip testing must be repeated on an annual or semiannual basis for low and medium risk and high risk level compounding respectively |
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Finished preparation release checks and tests
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-physical visual inspection for preparation integrity, absence of cores, other particulate matter, phase changes and discoloration
-verification of compounding accuracy conducted someone other than the compounded to ensure proper measurement, reconstitution and component usage -high risk level CSPs in groups of >25 must be tested according to USP chapter <71> sterility test and <85> bacterial endotoxin test -low and medium risk level CSPs that exceed the USP chapter guidelines for BUD must be tested according to USP Chapter <71> -Accurate labeling and determination of correct fill volumes or quantities are outlined in written procedures |
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What are the 13 issues addressed in <797>?
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1) The responsibility of compounding personnel to ensure that CSPs are prepared, stored, dispensed, and distributed safely
2) Contamination risk levels 3) Procedures to verify the accuracy and sterility of CSPs 4) Personnel training and evaluation 5) Verification of Automated Compounding Devices (ACDs) 6) Environmental quality and control 7) Checks and tests of finished preparations before dispensing 8) Storage and beyond-use dating 9) Product quality and control after the CSP leaves the pharmacy 10) Patient or caregiver training so they can store, administer, and dispose of the CSP 11) Patient monitoring to track their response to the therapy 12) The need for a feedback mechanism so patients and caregivers can report concerns about CSPs 13) A quality assurance program that documents CSP policies, processes, and procedures |
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List the steps towards 797 compliance
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1) Educate yourself on the new standards
2) Determine CSP risk level 3) Complete revised gap analysis to determine level of current compliance 4) Develop action plan 5) Prioritize action items 6) Report gap analysis results and action plan to staff 7) Assign action plan items and timelines to specific employees 8) Document all action plan progress 9) Continually reassess for compliance |
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True or False
Not all sterile compounds are assigned a risk level |
False
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True or False
When making a low-risk drug product, it is acceptable to use more than 3 commercially available products |
False
No MORE than 3 products can be used |
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True or False
Low-Risk Level with <12 Hr BUDs only require a ISO Class 5 hood for compounding |
True
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True or False
USP Chapter <608> outlines all pertinent safety rules for compounding sterile products |
False
What's the title of this card set called? |
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True or False
Medium Risk level products can be made from non-sterile products |
False
Only High Risk products are made from non-sterile products |
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True or False
Immediate-Use products cannot contain more than 1 product |
False
They can contain UP to 2 |
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True or False
PECs must be physically located within an ISO Class 7 buffer area |
True
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