USP Compounding Standards

GPTKB entity

Statements (51)
Predicate Object
gptkbp:instanceOf pharmaceutical standard
gptkbp:address gptkb:personal_protective_equipment_(PPE)
air quality
manual
quality assurance
labeling requirements
environmental monitoring
patient safety
risk assessment
waste disposal
sterility testing
incident reporting
equipment maintenance
personnel training
competency assessment
recall procedures
aseptic technique
beyond-use dating
cleaning procedures
cleanroom standards
compounding procedures
endotoxin testing
facility requirements
hazardous drug containment
product integrity
storage requirements
training documentation
gptkbp:appliesTo compounded medications
gptkbp:basisFor compounding pharmacy inspections
gptkbp:compatibleWith accreditation organizations
gptkbp:enforcedBy FDA (in some contexts)
state boards of pharmacy
gptkbp:firstPublished 2004 (USP <797>)
https://www.w3.org/2000/01/rdf-schema#label USP Compounding Standards
gptkbp:includes gptkb:USP_<795>
gptkb:USP_<797>
gptkb:USP_<800>
gptkbp:latestReleaseVersion 2023 (USP <795>, <797>, <800>)
gptkbp:maintainedBy gptkb:United_States_Pharmacopeia_(USP)
gptkbp:purpose ensure quality and safety of compounded preparations
gptkbp:referencedIn gptkb:Joint_Commission
gptkb:National_Association_of_Boards_of_Pharmacy_(NABP)
gptkbp:usedBy hospitals
pharmacies
healthcare professionals
compounding facilities
gptkbp:USP_<795>_covers nonsterile compounding
gptkbp:USP_<797>_covers sterile compounding
gptkbp:USP_<800>_covers handling hazardous drugs
gptkbp:bfsParent gptkb:United_States_Pharmacopeia
gptkbp:bfsLayer 6