USP 797 — sterile compounding answers
Sterile compounding questions pile up before inspections. Get a cited starting point in seconds — then confirm against your licensed text and rooms.
- USP 797 requires sterile agents inside the PEC — Yes — under USP 797, cleaning, disinfecting, and sporicidal agents used inside the primary engineering control (PEC) must be sterile, and water used to dilute those agents for PEC use is expected to be sterile too.
- How do I prepare for a USP 797 inspection? — An inspector can walk in while you are still hunting last year’s competency file. Stop scattering 14+ minutes across USP PDFs and shared drives. Organize what pharmacies commonly review — then get cited answers in seconds.
- What is a designated person under USP 797? — Failing to formally name who owns sterile compounding performance is a common deficiency theme. Get a clear educational definition — then ask Compounding AI Pro how the role shows up across training and SOPs in your pharmacy.
- What is a Category 1 CSP under USP 797 and what BUD applies? — A Category 1 BUD error is a patient-safety and inspection problem on the same label. Get the educational ≤12-hour room-temp / ≤24-hour refrigerated pattern straight — then confirm against your licensed USP tables and your room configuration.
- What order should techs don garb before they start in the hood under USP 797? — Stop guessing garb order from the last in-service. Get the typical 797 sequence as a starting point — then follow your current master SOP.
- What happens if a tech fails the fingertip test but passes the media fill? — A failed fingertip sample with a passing media fill still keeps that tech off the hood in most shops. Get the two checks straight — then confirm your licensed USP 797 text, SOP, and board before anyone compounds.
- Who is the Designated Person, and what do they actually have to do each year? — Naming someone on a form is not the same as knowing the yearly clock. This is an educational multi-chapter pattern. Confirm every duty and interval in your licensed USP text and board rules — do not treat this page as a cleared checklist.
- When do we need Category 3 dating instead of staying Category 2 under USP 797? — Longer sterile dating is not a label tweak. If you want BUDs past Category 2 table limits, you take the Category 3 controls package with it — then confirm every number in your licensed USP 797 tables.
- Which Master Formulation Record fields do USP ⟨795⟩ and ⟨797⟩ list? — An incomplete recipe or this-batch log still leaves those records unfinished. This page is the chapter-listed shape of those records — field names, not the numbers you fill in. Confirm every field in your licensed USP text, your SOP, and your board.
- Which USP edition does our state board actually enforce? — The newest USP PDF is not automatically the text in your inspector’s bag. Official USP dates and state enforcement dates are different clocks. Compounding AI Pro does not store which edition your board enforces. Open the board’s own posting — then ask the USP core question.