USP Standards and Regulations Flashcards

What is the USP position on commercially manufactured products versus compounded preparations?

Answer: Compounded preparations should only be used when a suitable commercial product is not available

Commercially available FDA-approved products should be used when available. Compounding is appropriate only when a suitable commercial product is not available.

What are key responsibilities under USP 797 quality assurance requirements?

Answer: Comprehensive responsibilities including QA plan, SOPs, training, environmental monitoring, corrective actions, and quality reviews

USP 797 requires a comprehensive QA program encompassing all aspects of the sterile compounding program.

How does the concept of first air relate to USP 797?

Answer: HEPA-filtered air flowing directly from the filter to the critical site without passing over any contaminating surface

First air is the HEPA-filtered air coming directly from the filter before passing over any object. Critical sites must maintain exposure to first air.

What is the significance of USP Chapter 795 in relation to USP 797?

Answer: USP 795 covers non-sterile compounding and works alongside USP 797 for comprehensive standards

USP 795 establishes standards for non-sterile compounding while USP 797 addresses sterile compounding.

What triggers a mandatory corrective action when environmental monitoring results exceed action levels?

Answer: Exceeding the defined action level for either viable or non-viable counts in any classified area

Any single result exceeding the established action level triggers a mandatory investigation and corrective action.

What documentation must a pharmacy maintain to demonstrate USP 797 compliance?

Answer: Comprehensive records including SOPs, training, competency assessments, environmental monitoring, equipment logs, MFRs, CRs, CAPA records, and quality reviews

USP 797 compliance requires extensive documentation covering every aspect of the sterile compounding program.