What is a designated person under USP 797?

Under USP 797, the compounding facility must designate one or more individuals (the designated person(s)) to be responsible and accountable for the performance and operation of the facility and personnel in the preparation of CSPs and for performing other functions described in the chapter. Responsibilities are woven through the chapter rather than living only in one checklist line.

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.

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What this means on the floor

Responsibilities are woven through the chapter rather than living only in one checklist line. Not legal advice. Not an inspection-outcome guarantee. Confirm against your licensed USP text and facility policies.

  • Document who the designated person(s) are (name/title, scope).
  • Map duties to training-program ownership, SOP oversight, and deviation/corrective-action paths.
  • Make sure staff can answer “who is the designated person?” consistently.
  • Ask Compounding AI Pro follow-ups against your uploaded training SOP.

State boards can add overlays

Boards may use different titles (for example designated pharmacist language on some sterile inspection forms) or add documentation expectations. Illustrative: Texas 22 TAC §291.133 sterile class context; California compounding documentation expectations under CCR 1735 (verify current board text). Verify locally.

Compounding AI Pro speeds USP and SOP lookup. It does not claim complete state-overlay automation as shipped.

FAQ

Can there be more than one designated person?
USP allows one or more individuals. Educational summary only — confirm in your licensed chapter.
Is designated person the same as PIC?
Often overlapping in small 503A settings, but the chapter defines a functional accountability role. Confirm how your facility documents both.
Why do inspectors care?
Formal designation and evidence of accountability are frequently discussed deficiency themes in compounding inspection commentary. Not an inspection-outcome guarantee.
Is this legal advice or an inspection guarantee?
No. PharmacyCompounding.AI educational pages and Compounding AI Pro support faster lookup; they are not legal advice and do not guarantee inspection outcomes.

Related

Educational information only. Not legal advice. Not an inspection-outcome guarantee. Keep a current USP Compendium subscription. PIC judgment and your board still govern.