Sterile Lecture 1: Kahoot 1 - Rules, Regulations & USP <797>
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10 Terms
Which organization develops USP <797>?
USP
Which USP chapter addresses sterile compounding?
USP <797>
Which statement about USP is correct?
USP develops quality standards
Which FDCA section is associated with outsourcing facilities?
503B
A traditional patient-specific compounding pharmacy is most associated with which pathway?
503A
Which situation may result in FDA involvement with a 503A compounder?
A complaint or adverse drug event
Which organization oversees pharmacy practice at the state level?
State pharmacy regulatory body
Form FDA 483 is used to document:
Inspectional observations
Which act created the modern 503B outsourcing-facility framework discussed in class?
OSHA Act
Which statement is FALSE?
USP licenses all 503A pharmacies