Federal RequirementsQuestion 50 of 100
Which standard governs compounded sterile preparations, including ISO-classified air, garbing, and assignment of beyond-use dates?
a.USP <795>
b.USP <800>
c.USP <797>
d.21 CFR 1304
Explanation
USP <797> sets the practice standards for compounded sterile preparations, covering ISO-classified engineering controls, personnel hand hygiene and garbing, environmental monitoring, and beyond-use dating. USP <795> applies to nonsterile compounding such as creams and oral suspensions, while USP <800> addresses handling of hazardous drugs regardless of whether the preparation is sterile. 21 CFR 1304 concerns controlled substance recordkeeping and has nothing to do with compounding technique.
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