Federal RequirementsQuestion 51 of 100
A technician will compound a chemotherapy agent in a negative-pressure containment room while wearing a chemotherapy-rated gown and two pairs of chemotherapy-rated gloves. Which standard drives these requirements?
a.USP <800>
b.USP <795>
c.USP <797>
d.Drug Supply Chain Security Act (DSCSA)
Explanation
USP <800> governs the receipt, storage, compounding, and disposal of hazardous drugs in order to protect personnel, patients, and the environment, and it specifies containment engineering controls such as negative pressure rooms plus chemotherapy-rated PPE. Drugs subject to <800> are identified from the NIOSH hazardous drug list. USP <795> and <797> address nonsterile and sterile compounding quality rather than worker exposure, and the DSCSA deals with tracing product through the supply chain.
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