USP 797 Section 21: Compounding Compliance for Allergy Practices

For years, allergy practices compounding their own allergenic extracts operated outside USP General Chapter 797. That changed when Section 21 took effect on November 1, 2023, written specifically to cover the preparation of allergenic extract prescription sets.

If your practice mixes its own immunotherapy, this applies to you. And unlike most compliance obligations, it lands on individual named people rather than on the practice in the abstract.

The designated person

Section 21 requires a designated person with training and expertise in allergen immunotherapy who is responsible for ensuring that everyone preparing extracts is trained, evaluated, and supervised.

This is a named role, not a shared responsibility. When something goes wrong — a failed competency, a contamination event — the designated person is the one who identifies the cause and determines what retraining is required.

Training before independent compounding

Before anyone independently prepares allergenic extracts, they must complete training and demonstrate knowledge of the principles and skills of sterile compounding. Demonstration means passing written or electronic testing — not simply attending a session or signing an attendance sheet.

That distinction matters. A training record showing someone sat through a course is not evidence of competency under Section 21. The assessment is the evidence.

Annual competency, documented

Personnel training and competency must be documented annually. This is the requirement most likely to lapse quietly, because it is a recurring obligation attached to each individual rather than a one-time practice-level task.

A practice with four compounders has four separate annual clocks, each starting on a different date depending on when that person was last evaluated. Tracking that on a spreadsheet works right up until someone goes on leave, returns, and nobody notices their evaluation expired.

Media fill testing

Alongside aseptic technique, compounding personnel must pass a media fill test annually. A media fill simulates the compounding process using growth medium in place of extract — if the medium stays sterile, the technique held.

It is a direct test of the person, not the room or the equipment, which is what makes it the practical centerpiece of the competency requirement.

Hand hygiene and garbing

Before compounding, personnel perform hand hygiene and garbing according to the facility's standard operating procedures. Garb must be low lint, fitted at the wrists and neck, and include head covers, masks, and sterile powder-free gloves.

Note the dependency: the requirement points at your SOPs. If the practice has never written them down, there is nothing for personnel to follow and nothing for an inspector to evaluate against.

Two rules that catch practices out

Failed evaluations require targeted remediation. Personnel who fail a competency evaluation must pass reevaluation in the deficient areas before resuming compounding. The designated person identifies the cause of the failure and determines the retraining. A general retake does not satisfy this — the remediation has to address what actually failed.

The six-month lapse rule. Anyone who has not compounded an allergenic extract prescription set in more than six months must be evaluated in all core competencies before resuming. This is the one practices discover too late: a compounder returning from extended leave, or a physician who covers only occasionally, cannot simply pick it back up.

Who inspects this

USP standards are enforced through state boards of pharmacy and, depending on the state, through other regulators and accreditation bodies. Enforcement varies considerably, which has led some practices to treat Section 21 as advisory.

That is a risky read. The standard is written, dated, and specific about personnel qualification. A practice that cannot produce current annual competency records for each compounder has a documentation gap that is easy for an inspector to establish and difficult to explain.

What to have on file

For each person who compounds:

• Initial training records and the passing assessment
• Current annual competency documentation, dated
• Current annual media fill test result
• Hand hygiene and garbing evaluation
• For anyone with a lapse over six months: full re-evaluation before resuming
• For any failure: the identified cause, the retraining, and the passing reevaluation

Plus, at practice level: the designated person identified by name, and written SOPs covering hand hygiene, garbing, and the compounding process itself.

The practical problem

None of these requirements is individually difficult. The difficulty is that they are per person, per year, on staggered dates, with a six-month lapse rule running underneath.

Most practices that fall out of compliance with Section 21 do not do so by ignoring it. They do so by losing track of one person's date — which is a tracking problem, not a knowledge problem.