USP 797 Part 3

what must initial competency be demonstrated in before compounding?

hand hygiene, garbing, post-garbing fingertip and thumb test, and aseptic processing (media fill, gloved fingertip and thumb testing)

when does visual observation of hand hygiene occur for category 1&2

every 6 months

when does visual observation of hand hygiene occur for category 3

every 3 months

when does visual observation of garbing and gloving technique occur for category 1&2

every 6 months

when does visual observation of garbing and gloving technique occur for category 3

every 3 months

what are the gloved fingertip and thumb test?

sample collected from each hand, Trypticase soy agar that has been neutralized is used and incubated for 7 days then inspected for microbial growth (growth measured in colony-forming units)

what is the first test for gloved fingertip and thumb test (post-garbing)

demonstrates ability to garb without contaminating yourself

what is the second gloved fingertip and thumb test (post-media fill)

demonstrates ability to maintain asepsis during compounding

how does the initial gloved fingertip and thumb test work

is completed after garbing three separate time (repeating full hand hygiene and garbing each time), completed once after media fill test

when do requalification tests occur for gloved fingertip/thumb tests in category 1 and 2

every 6 months

when do requalification tests occur for gloved fingertip/thumb tests in category 3

every 3 months

what are medial fill tests

simulates sterile compounding, used to demonstrate competency in aseptic technique/compounding, should simulate most complex CSP

how does media fill testing work

also known as process simulation, drug product is replaced with sterile culture media (tryptic soy broth), incubate for two weeks

what is considered a pass for media fill testing

no turbidity or color change

after passing the media fill test, when does it need to be done again in category 1 and 2?

every 6 months

after passing the media fill test, when does it need to be done again in category 3

every 3 months

what is active air sampling

measured volume of air is drawn into a device that contains an agar plate, agar plate in incubated to detect microbial growth

after active air sampling is done initially when does it have to be redone for category 1 and 2

every 6 months

after active air sampling is done initially when does it have to be redone for category 3

monthly

what is surface sampling

sampling surfaces exposed to sterile compounding with a plate containing growth media (PEC deck, equipment in PEC, staging areas near PEC, frequently touched surfaces)

after surface sampling is done initially, when is it redone for category 1 and 2

monthly

after surface sampling is done initially, when is it redone for category 3

weekly

what is terminal sterilization

destruction of microorganisms

what is filtration sterilization

physical removal of organisms

when is terminal sterilization required?

CSPs compounded using any nonsterile ingredients

examples of terminal sterilization

steam sterilization (autoclave), dry-heat sterilization (dehydrogenation), gas sterilization, ionizing radiation

what are pyrogens

metabolic by-products of living microorganisms - Rarely fatal, but cause significant discomfort: fever, chills, increased blood pressure, dilated pupils, decreased respiration, nausea and malaise, severe diarrhea, or pain in the back and legs

T/F: heated sterilization methods cannot be used on heat-sensitive drugs

true

when do we need master formulation records?

all CSPs prepared from nonsterile ingredient (s) and CSPs prepared for multiple patients

when do we use compounding records

category 1,2,3 CSPs, immediate use CSP prepared for multiple patients, can be prescription or medication order or label, can be stored electronically (retrievable, required information)

what are release inspections

all completed CSPs must be visually inspected before dispensing (discoloration particulates, cloudiness)

which category CSP does bacterial endotoxin testing?

category 2 injectable CSPs compounded from one or more nonsterile components and assigned a BUD that requires sterility testing

category 3 injectable CSPs compounded from one or more nonsterile components

what goes on labels

assigned internal identification number, active ingredients (amount/activity/concentration), dosage form, amount/volume in container, storage temp if other than CRT, BUD, SDC vs MDC

labeling requirements

indication that the preparation is compounded, route of administration, special handling, applicable warning statement, name, address, and contact info of compounding facility if the CSP will be sent outside the facility where it was compounded