Non-Sterile Compounding
Compounding Risk Assessment & Master Formulation Record
Screens an extemporaneous preparation against this pharmacy's NAPRA Level A capability, then builds the risk assessment and Master Formulation Record. This record describes a preparation, not a patient — no patient information is collected.
Auto-set to 12 months after the effective date. Editable — review sooner if practice, ingredients, or standards change (Policy §7.2.1).
Optional. Leave blank to print an empty signature line.
Optional. Leave blank to print an empty signature line for an independent pharmacist to sign by hand (Policy §7.2.5).
All three approval names — Developed By, Verified By and the Non-Sterile Compounding Supervisor — may be left blank and signed by hand on the printed record. None of them block the record from being generated.
List every ingredient, including commercial products, active pharmaceutical ingredients and excipients.
For a manipulated commercial product, use the SDS for the assumed base active ingredient
(e.g. crushing Septra® tablets → assess against the sulfamethoxazole USP SDS).
HMIS ratings and the PPE letter drive the hazard gate, so every row needs them.
No ingredients yet. Add the first one below.
Step 1 — Identify what's involved
Step 2 — Simple admixture fast-pass
Does this preparation involve only the mixing of commercially available products,
with no crushing, triturating or other manipulation? (For example, mixing two creams together, or mixing two or more liquid products in a single container.)
Step 4 — Screening result
Optional. Leave blank to print an empty signature line.
A1 — NIOSH List of Hazardous Drugs
A2 — WHMIS / SDS health hazard
Are any ingredients identified by WHMIS/SDS (Section 2) as presenting a health hazard?
A3 — NIOSH / WHMIS / monograph indications
A4 — Compounding risks
Is there a risk of the following when compounding this preparation? Check all that apply — each ticked box requires a matching mitigation in Section C.
Select all that apply.
—
Set in Level A Screening — Step 3, where it drives the hazard gate.
| PPE | Required? | Type (be specific) |
|---|---|---|
| Eye protection | ||
| Dust Mask | ||
| N95 Mask | ||
| N100 Mask | ||
| Face shield | ||
| Gloves | ||
| Gown / lab coat | ||
| Other PPE |
Surgical masks and non-NIOSH-certified masks do not provide respiratory protection against drug exposure and must not be substituted when respiratory protection is required.
Mitigation of the risks identified in Section A
| Risk (ref. Section A4) | Mitigation measure(s) |
|---|---|
| Microbial contamination | |
| Cross-contamination | |
| Interruption to workflow | |
| Other risk(s) |
Level A
This pharmacy compounds to Level A requirements only, and the Level A Screening above has already made this determination (Policy §7.1).
Formula
Drawn from the Ingredients section. Physical description and additional information are entered on each ingredient row.
Required equipment, instruments and materials (including PPE)
Compounding Method
Number your own steps. Best practice is to start with Step 1 describing how to calculate the addition to
quantities that accounts for product loss (Policy §7.3). Leave quantities as blanks —
this method is printed on the Mixture Record and filled in by hand at the time of compounding. For example:
What will be checked on the finished preparation, and what result is expected.
No quality controls yet.
Signature lines print blank on the PDF for wet signature.
—
Set in Document Control.
—
Set in Document Control. May be left blank to be signed by hand later.
Optional. Leave blank to print an empty signature line. Must have completed OCP's Non-Sterile Compounding Supervisor Training Course (Policy §7.2.5).
Once this record is approved, create the matching mixture record in Kroll (Policy §7.4).
Copy the name and the instructions below straight into it.