Why USP <797> QA documentation is in focus
USP General Chapter <797> sets minimum standards for compounding sterile preparations (CSPs). The revision published on November 1, 2022 became official on November 1, 2023, although state boards of pharmacy may set their own dates. USP itself has no enforcement role: boards of pharmacy, accreditors and, for some facilities, FDA enforce it.
With the revised chapter now in its third year, inspectors are past the “did you update your SOPs” stage and are asking for evidence that the quality program operates. That is why searches for QA program documentation jumped in 2026.
What the QA/QC program must cover
The 2023 chapter places quality assurance and quality control in its own section. Based on USP’s FAQs and summaries by ASHP and Wolters Kluwer, a compliant program has these components.
| Component | What to document |
|---|---|
| Written QA/QC program and SOPs | SOPs describing how errors are prevented and detected, including how complaints and adverse events are evaluated and followed up (Wolters Kluwer) |
| Annual review | QA/QC program reviewed at least once a year, covering SOPs, quality improvement outcomes, errors and tracked metrics |
| SOP review | SOPs written and reviewed every 12 months by a designated person |
| SOP training | All personnel who perform or oversee compounding or support activities trained in the SOPs |
| Designated person | Named person(s) responsible and accountable for CSP operations, with qualifications defined in SOPs |
| Release inspection | Every CSP visually inspected before release or dispensing, per the master formulation record |
| Recall SOP | Procedures for severity and urgency, distribution, identifying patients who received the CSP, disposal and documentation, and investigating the failure |
| Records | Master formulation records, compounding records, personnel evaluations, environmental monitoring, certification and corrective actions |
Master formulation and compounding records
ASHP’s comparison of the 2008 and 2023 chapters notes two major documentation additions: a master formulation record is required for CSPs prepared for more than one patient or from nonsterile components, and a compounding record is required for all Category 1, 2 and 3 CSPs and for immediate-use CSPs prepared for more than one patient. USP’s FAQ adds that process, ingredient or packaging changes are noted on the compounding record rather than by altering the master formulation record.
Personnel evaluation records
USP’s FAQ states that all gloved fingertip, thumb and media-fill evaluation results must be documented, not only those that exceed action levels. Failed evaluations need documented corrective action.
Release and sterility testing
Category 2 and 3 CSPs that require sterility testing may be dispensed before results are available only if the facility has procedures to notify the prescriber of failures, recall unused CSPs, quarantine stock and investigate other affected lots. That procedure, and evidence it is followed, is part of the QA file.
Environmental monitoring and certification
Public inspection worksheets, such as Washington State’s USP <797> self-inspection addendum, ask whether certification records are reviewed by the designated person, whether corrective action plans are documented for out-of-range results, and whether sampling data are reviewed for trends with the review documented.
Building the documentation set
- Map the chapter to SOPs. Create a matrix of every chapter requirement and the SOP that addresses it.
- Name the designated person(s) and record their qualifications and delegated duties.
- Define records and retention. Check your state board of pharmacy rules for retention periods, which vary by jurisdiction.
- Set the annual review. Schedule the QA/QC program review with a standard agenda: SOP changes, errors, complaints, adverse events, recalls, environmental and personnel monitoring trends, and metrics.
- Link deviations to CAPA. Every out-of-range result or failed evaluation should have a documented investigation and corrective action.
- Run a self-inspection with your state’s worksheet before the board does.
Common weaknesses
- SOPs updated for 2023 but not reviewed again within 12 months.
- Annual QA/QC review held informally with no record of metrics reviewed.
- Only failing fingertip or media-fill results documented.
- Recall SOP that covers notification but not patient identification or root-cause investigation.
- Environmental monitoring data collected but not trended.
- Designated person named but duties and delegation not written down.
Checklist: USP <797> QA program documentation
- Written QA/QC program describing error prevention and detection
- Complaint and adverse event evaluation procedures
- Recall SOP with all required elements
- SOPs reviewed in the last 12 months by a designated person
- SOP training records for everyone who compounds, oversees or supports compounding
- Master formulation and compounding records for applicable CSPs
- All personnel evaluation results documented, with corrective actions
- Environmental monitoring trended and reviewed, with documented follow-up
- Annual QA/QC program review minutes with metrics
- Retention periods aligned with state board rules
How AskDona helps
A sterile compounding QA file spans SOPs, training logs, monitoring data, compounding records and review minutes. AskDona reads that file against the USP <797> requirements and your state’s inspection worksheet, shows which requirement each document supports, and flags gaps such as overdue SOP reviews or missing corrective actions, with citations to the page. Run a sample USP <797> documentation gap check before your next board inspection. AskDona shows the evidence; your designated person decides.
Editor’s note: The full text of USP <797> is behind a subscription, so requirements are drawn from USP’s public FAQs, ASHP and NHIA summaries, a Wolters Kluwer article and a state inspection worksheet. Retention periods are deliberately not stated because they vary by state. Confirm details against the official chapter and your board of pharmacy.
FAQ
Does USP <797> require a written quality assurance program? Yes. The revised chapter has a dedicated QA/QC section, and summaries describe written SOPs for error prevention and detection, complaint and adverse event handling, and recalls.
How often must USP <797> SOPs be reviewed? At least every 12 months, by a designated person.
How often is the QA/QC program reviewed? At least once a year, covering SOPs, quality improvement outcomes, errors and metrics.
What must a USP <797> recall SOP include? Assessment of severity and urgency, distribution of the affected CSP, identification of patients who received it, disposal and documentation, and investigation of the cause.
When did revised USP <797> become official? November 1, 2023, although state boards may use different dates.
References
All pages opened and checked by October 23, 2026.
| Source | Type | Used for |
|---|---|---|
| USP <797> FAQs (Dec 2023) | Standards body | Official date, designated person, records, release, recall |
| ASHP: USP 797 Key Changes | Professional society | 2008 vs 2023 changes |
| NHIA: Revised USP Sterile Compounding Standards | Professional association | SOP review every 12 months |
| Wolters Kluwer | Publisher / vendor | QA/QC SOP content and annual review |
| Washington DOH self-inspection addendum | State regulator | Inspection questions |