FIPP 6: USP 797 and 800
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Galen Pharmacology Test 1 Medication Aide Level 1 CNJNE IVE Adult IV therapy 2023 NUR 25
Teacher 40 terms Teacher 356 terms Teacher 61 terms Teacher
daudimutuamwende Preview ann-chelley Preview carrosa254 Preview wak
USP -the United States Pharmacopeia (USP) is an organization that sets international
standards for pharmaceuticals
-over 1000 chapters
-those below 1000 are enforceable by FDA and may also be enforced by state
boards of pharmacy
-NAPLEX will test your understanding of USP standards related to pharmacy
practice
USP chapters to know -795 = NONSTERILE COMPOUNDING
-797 = STERILE COMPOUNDING
-800 = HAZARDOUS COMPOUNDS (can be nonsterile and sterile)
sources of contamination -HUMAN TOUCH IS THE #1 SOURCE OF CONTAMINATION
-water or other aqueous vehicles
-equipment
-chemicals
-containers and closures
sterility absence of viable microorganisms
sterilization process or method by which all viable forms of microorganisms are removed or
destroyed
pyrogen fever producing organic substance arising from a microbe's outer cell wall and/or
endotoxins
depyrogenation -destruction of pyrogens from a solution
-usually in terms of injectable medications
scope of sterile compounding -compounding in an environment that utilizes various measures to prevent any
microbial contamination
-STERILE COMPOUNDING DOESN'T INCLUDE RECONSTITUTION
, sterile compounding measures include -primary engineering controls (PECs) (hoods, HEPA filters)
-secondary engineering controls (SECs) (ante rooms, buffer room)
-gowning/garbing procedures
-disinfectants and cleaning supplies
USP 800 -hazardous drugs guidelines
-national institute for occupational safey and health (NIOSH) considers a drug to
be hazardous if it exhibits certain characteristics (carcinogenicity, teratogenicity,
etc) in humans or animals
-all sterile compounding from USP 797 requirements apply to hazardous drugs
but additional requriement will also apply
-ex. chemotherapy (antineoplastics
-hormonal agents
what makes a drug hazardous expressing:
-carcinogenicity
-teratogenicity
-developmental toxicity
-reproductive toxicity
-organ toxicity at low doses
-genotoxicity
in animals or humans
hazardous drug -pose risks of cancer, organ toxicity, or reproductive harm to healthcare workers,
pharmacists, and staff who handle them.
-need to follow USP 797 (for sterile compounds) plus additional rules
-ex. chemo drugs
airborne contaminants -sterile compounding facilities must minimize the risk of airborne contamination
-want the "cleanest" air in any area in which sterile compounding occurs
-clean air is based on international standards organization (ISO) classifications
international standards organization (ISO) classifications -3 is the "clearnest" air = 35.2 particle count/m3 of airborne contamination
-8 is the "dirtest" air = 3520000 particle count/m3 of airborne contamination
-buffer room should be at ISO 7
-ante room should be at ISO 8
clearn room model -there are 3 distinct areas/layers
-each with a different level of air cleanliness
1) Ante area
2) buffer area (aka clean room)
3) compounding area (PEC)
Hallway → Ante-room → Buffer room (ISO 7) → PEC (ISO 5)
ante-area -must meet at least ISO class 8 standards (per USP 800 it should be ISO class 7)
-hand hygiene, garbing, order entry CSP handling, etc happens here
-no compounding allowed in this area
-even tho it is ISO 8 or 7, it does NOT have controlled airflow patterns for
compounding or have proper pressure differentials for product protection
Edit Save
Students also studied
Galen Pharmacology Test 1 Medication Aide Level 1 CNJNE IVE Adult IV therapy 2023 NUR 25
Teacher 40 terms Teacher 356 terms Teacher 61 terms Teacher
daudimutuamwende Preview ann-chelley Preview carrosa254 Preview wak
USP -the United States Pharmacopeia (USP) is an organization that sets international
standards for pharmaceuticals
-over 1000 chapters
-those below 1000 are enforceable by FDA and may also be enforced by state
boards of pharmacy
-NAPLEX will test your understanding of USP standards related to pharmacy
practice
USP chapters to know -795 = NONSTERILE COMPOUNDING
-797 = STERILE COMPOUNDING
-800 = HAZARDOUS COMPOUNDS (can be nonsterile and sterile)
sources of contamination -HUMAN TOUCH IS THE #1 SOURCE OF CONTAMINATION
-water or other aqueous vehicles
-equipment
-chemicals
-containers and closures
sterility absence of viable microorganisms
sterilization process or method by which all viable forms of microorganisms are removed or
destroyed
pyrogen fever producing organic substance arising from a microbe's outer cell wall and/or
endotoxins
depyrogenation -destruction of pyrogens from a solution
-usually in terms of injectable medications
scope of sterile compounding -compounding in an environment that utilizes various measures to prevent any
microbial contamination
-STERILE COMPOUNDING DOESN'T INCLUDE RECONSTITUTION
, sterile compounding measures include -primary engineering controls (PECs) (hoods, HEPA filters)
-secondary engineering controls (SECs) (ante rooms, buffer room)
-gowning/garbing procedures
-disinfectants and cleaning supplies
USP 800 -hazardous drugs guidelines
-national institute for occupational safey and health (NIOSH) considers a drug to
be hazardous if it exhibits certain characteristics (carcinogenicity, teratogenicity,
etc) in humans or animals
-all sterile compounding from USP 797 requirements apply to hazardous drugs
but additional requriement will also apply
-ex. chemotherapy (antineoplastics
-hormonal agents
what makes a drug hazardous expressing:
-carcinogenicity
-teratogenicity
-developmental toxicity
-reproductive toxicity
-organ toxicity at low doses
-genotoxicity
in animals or humans
hazardous drug -pose risks of cancer, organ toxicity, or reproductive harm to healthcare workers,
pharmacists, and staff who handle them.
-need to follow USP 797 (for sterile compounds) plus additional rules
-ex. chemo drugs
airborne contaminants -sterile compounding facilities must minimize the risk of airborne contamination
-want the "cleanest" air in any area in which sterile compounding occurs
-clean air is based on international standards organization (ISO) classifications
international standards organization (ISO) classifications -3 is the "clearnest" air = 35.2 particle count/m3 of airborne contamination
-8 is the "dirtest" air = 3520000 particle count/m3 of airborne contamination
-buffer room should be at ISO 7
-ante room should be at ISO 8
clearn room model -there are 3 distinct areas/layers
-each with a different level of air cleanliness
1) Ante area
2) buffer area (aka clean room)
3) compounding area (PEC)
Hallway → Ante-room → Buffer room (ISO 7) → PEC (ISO 5)
ante-area -must meet at least ISO class 8 standards (per USP 800 it should be ISO class 7)
-hand hygiene, garbing, order entry CSP handling, etc happens here
-no compounding allowed in this area
-even tho it is ISO 8 or 7, it does NOT have controlled airflow patterns for
compounding or have proper pressure differentials for product protection
