Statements (50)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmaceutical compounding standard
|
| gptkbp:appliesTo |
hospitals
pharmacies healthcare professionals compounding facilities compounding of allergen extracts compounding of radiopharmaceuticals compounding of sterile biologics compounding of sterile drugs compounding of veterinary sterile preparations |
| gptkbp:countryOfOrigin |
gptkb:United_States
|
| gptkbp:covers |
compounded sterile preparations (CSPs)
|
| gptkbp:documentType |
compendial standard
|
| gptkbp:enforcedBy |
accreditation organizations
FDA (in some contexts) state boards of pharmacy |
| gptkbp:excludes |
nonsterile compounding
administration of drugs manufacturing of drugs |
| gptkbp:firstPublished |
2004
|
| gptkbp:focusesOn |
sterile compounding
|
| https://www.w3.org/2000/01/rdf-schema#label |
USP <797>
|
| gptkbp:includes |
requirements for documentation
requirements for personnel training requirements for quality assurance requirements for beyond-use dating requirements for cleaning and disinfecting requirements for environmental monitoring requirements for facility design requirements for garbing and hand hygiene requirements for risk levels of CSPs |
| gptkbp:issuedBy |
gptkb:United_States_Pharmacopeia_(USP)
|
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
2022
|
| gptkbp:officialName |
Pharmaceutical Compounding – Sterile Preparations
|
| gptkbp:purpose |
to ensure patient safety
to prevent harm from incorrect ingredient strength to prevent harm from microbial contamination to prevent harm from chemical and physical contaminants to prevent harm from excessive bacterial endotoxins |
| gptkbp:referenceNumber |
<797>
|
| gptkbp:relatedTo |
gptkb:USP_<795>
gptkb:USP_<800> |
| gptkbp:replacedBy |
previous versions of USP <797>
|
| gptkbp:riskLevels |
Category 3
Category 1 Category 2 |
| gptkbp:startDate |
November 1, 2023
|
| gptkbp:bfsParent |
gptkb:USP_Compounding_Standards
|
| gptkbp:bfsLayer |
7
|