Compounding: USP 797 Flashcards
Compounding facilities: 503A facilities- what do they do?
Traditional compounding
What do 503A facilities do?
Pharmacies perform the compounding pursuant to a script and are allowed to compound items when there’s a shortage of a commercially available drugs
Compounding facilities: 503B facilities- what do they do?
Outsourcing facilites
What do 503B facilities do?
Allows compounders to manufacture products without a script
What do 503B facilities have to follow?
GMPs as prescribed by the FDA and have to volunteer to inspections by the FDA
Examples of preparations that are CSPs
Infusions
Injections
Aqueous preparations for pulmonary inhalations
Irrigation for internal body categories
Anything that goes into the eye
Implants
Baths and soaks for live organs
Do USP 797 standards apply to manufacturing?
No
Do USP standards apply to preparing sterile products following a manufacturer’s approved labeling?
No, this is only for a single patient and won’t be stored
Immediate use CSP: is it considered compounding?
No
How are immediate use CSPs prepared?
Using the manufacturer’s labeling instructions
Who can use an immediate use CSP? (Who is it for?)
A single patient
When to administer an immediate use CSP
Within 4 hours of making it
Can hazardous drugs be made as immediate use products?
No
Do personnel need to use aseptic technique when making an immediate use compound?
YES, they need to be trained and demonstrate competency
Who needs to comply with 797?
All pharmacies that perform sterile compounding
Nursing home compliance with 797: who is preparing the CSPs?
The pharmacy (duhhhhh)
If products are made according to the manufacturer’s approved label, does it need to follow USP standards?
No. It needs to be for a single patient, can’t be stored for future use, and limited to nonhazardous drugs
What does prepackaging and repackaging fall under?
USP 797
Why does prepacking and repackaging fall under 797?
It involves sterility and stability
USP 797 products need assessments of what?
Change of container and closure
Responsibilities of the designated person overseeing USP 797 compounding
Developing and implementing policies and procedures
Establishing a training program
Overseeing compliance
Selecting components
Ensuring environmental controls for compounding and storing products
Does a designated person have to be a pharmacist?
No, but it’s most likely going to be one. Some states may select a tech and some practices may not have a pharmacist to serve in this role
Can one person be the designated person for multiple sites?
Yes
Where does a designated person receive their training?
Via ASHP with didactic and hands-on experience; they have certificate programs in sterile compounding
Activities a designated person must do: USP 797
Compliance with 797, applicable federal and state laws and regulations, accreditation statements
Oversight of personnel training, competency documentation, and monitoring
Oversight of facility use and monitoring
Establish SOPs
Develop master formulation records
Monitor BUDs
Personnel competency requirements for USP 797: what should they be trained in?
Organizational policies and procedures
Use of garb
Use of equipment
Selection of components
Spill management
Personnel competency requirements: what should happen BEFORE they can compound?
They have to show competency and it has to be documented
Personnel competency requirements: how do personnel requalify?
Showing competency in garbing and gloved fingertip testing
Media fill and post medial fill gloved fingertip testing
Surface sampling
How often do personnel have to requalify in competency if they’re compounding Category 1 and 2 CSPs? (797)
q6 months
How often do personnel have to requalify in competency if they’re compounding Category 3 CSPs? (797)
q3 months
How often do personnel who oversee 797 compounding but don’t directly compound have to recertify? (Also includes designated person)
Once a year
Requirements for a Category 1 CSP (4 things)
ISO 5 PEC
Unclassified SCA
Sterile ingredients
No additional testing
Requirements for a Category 2 CSP (3 things)
Cleanroom suite
Sterile or nonsterile ingredients
Aseptic processing
Requirements for a Category 3 CSP (3 things)
Cleanroom suite
Sterile or nonsterile ingredients
Additional garbing, cleaning, etc. requirements
Initial testing for personnel, designated person, and personnel with direct oversight of compounders: what do they have to do?
Pass these 3 times sequentially:
Media fill test
Gloved fingertip and thumb test
Have to complete hand hygiene and full garbing procedure after each attempt
Key competency areas for personnel
Hand hygiene
Garbing
Knowledge of compounding technique
Proper movement of materials
Cleaning and disinfecting
Calculations
Measuring and mixing
Aseptic technique
Achieving and maintaining sterility
Proper use of equipment
Documentation
Gloved fingertip and thumb test: initial training
Must be done and passed 3 times before beginning to compound- if one is failed, you have to start over and perform 3 again
Purpose of the gloved fingertip and thumb test
Involves checking to ensure personnel maintain aseptic technique during the process
When is the gloved fingertip and thumb test done?
After handwashing and garbing
What is used for the gloved fingertip and thumb test?
Agar plates, they get incubated after the test
When is the media fill test done?
After sterile compounding
What’s tested in a media fill test?
Aseptic technique, sterility of the environment, transfer of components, equipment handling
What’s used in a media fill test?
Triptic soy broth (TSB), and then it’s incubated for 14 days
Passing the fingertip test
No growth from both hands (no CFUs)
Passing the media fill test
The TSB is clear, no turbidity
Definitions: PEC
Primary engineering control, aka the IV hood
Definitions: SEC
Secondary engineering control, aka the room the hood is in
Examples of SECs
Buffer room, anteroom, SCAs
ISOs
International organization for standardization, classifies the air cleanliness for cleanrooms
ISO for a PEC
ISO 5 or lower
ISO for a buffer room
ISO 7 or lower
What kind of pressure has to be in the anteroom?
Positive pressure, to reduce contamination
ISO for an anteroom if it opens up to a negative pressure room
ISO 7
ISO for an anteroom if it opens up to a positive pressure room
ISO 8 or lower
ACPH for an anteroom that opens up ONLY into a positive pressure buffer room
20
ACPH for an anteroom that opens into ANY negative buffer room
30
ACPH for a positive pressure buffer room
30
ACPH for a negative pressure buffer room
30
Up to 15 ACPH can come from where?
A PEC that’s vented back into the room
Generally speaking, do you want to use the same area to compound nonhazardous and hazardous drugs?
No, there needs to be separate areas for compounding each product
Environmental testing for Category 1 and 2 compounds: air sampling should be done how often?
Every 6 months
Environmental testing for Category 1 and 2 compounds: surface sampling should be done how often?
Every month
Environmental testing for Category 3 compounds: air sampling should be done how often?
Monthly
Environmental testing for Category 3 compounds: surface sampling should be done how often?
Weekly
Expiration date definition
Official date of expiry set by the manufacturer of a product
BUD definition
Day of expiry set by the compounder for drug preparation
In-use time definition
Timeframe from when a product or preparation is punctured or opened until the point it can no longer be used
Infusion time definition
Time a product or preparation is being administered to a patient
BUD dating for Category 1 CSPs: at room temp
≤12 hours
BUD dating for Category 1 CSPs: in the fridge
≤24 hours
BUD for Category 2 CSPs: NOT aseptically processed and prepared with at least one non-sterile component at ROOM TEMP
1 day
BUD for Category 2 CSPs: NOT aseptically processed and prepared with at least one non-sterile component in THE FRIDGE
4 days
BUD for Category 2 CSPs: NOT aseptically processed and prepared with at least one non-sterile component in THE FREEZER
45 days
BUD for Category 2 CSPs: NOT aseptically processed and prepared with ONLY STERILE components at ROOM TEMP
4 days
BUD for Category 2 CSPs: NOT aseptically processed and prepared with ONLY STERILE components in THE FRIDGE
10 days
BUD for Category 2 CSPs: NOT aseptically processed and prepared with ONLY STERILE components in THE FREEZER
45 days
BUD for Category 2 CSPs: ASEPTICALLY processed at ROOM TEMP
30 days
BUD for Category 2 CSPs: ASEPTICALLY PROCESSED in THE FRIDGE
45 days
BUD for Category 2 CSPs: ASEPTICALLY PROCESSED in THE FREEZER
60 days
BUD for Category 2 CSPs: NOT TERMINALLY STERILIZED at ROOM TEMP
14 days
BUD for Category 2 CSPs: NOT TERMINALLY STERILIZED in THE FRIDGE
28 days
BUD for Category 2 CSPs: NOT TERMINALLY STERILIZED in THE FREEZER
45 days
BUD for Category 2 CSPs: TERMINALLY STERILIZED at ROOM TEMP
45 days
BUD for Category 2 CSPs: TERMINALLY STERILIZED in THE FRIDGE
60 days
BUD for Category 2 CSPs: TERMINALLY STERILIZED in THE FREEZER
90 days
BUD for Category 3 CSPs: aseptically prepared, sterility tested, and passed all required tests AT ROOM TEMP
60 days
BUD for Category 3 CSPs: aseptically prepared, sterility tested, and passed all required tests IN THE FRIDGE
90 days
BUD for Category 3 CSPs: aseptically prepared, sterility tested, and passed all required tests IN THE FREEZER
120 days
BUD for Category 3 CSPs: terminally sterilized, sterility tested, passed all required tests IN ROOM TEMP
90 days
BUD for Category 3 CSPs: terminally sterilized, sterility tested, passed all required tests IN THE FRIDGE
120 days
BUD for Category 3 CSPs: terminally sterilized, sterility tested, passed all required tests IN THE FREEZER
180 days
BUD for a single-dose container OUTSIDE of an ISO 5 environment
1 hour from the time of puncture or opening
BUD for a single-dose container INSIDE of an ISO 5 environment
Up to 6 hours from the time of puncture or opening
BUD for a single-dose container (specifically an AMPULE) inside OR outside of an ISO 5 environment
Any leftover contents have to be discarded and can’t be stored
BUD for a multi-dose container inside OR outside of an ISO 5 environment
Up to 28 days from the time of puncture or opening unless otherwise stated by the manufacturer
