Compounding Record

---
name: compounding-record
description: "Write a compounding worksheet and record that reproduces the preparation exactly and survives inspection — formula, calculations shown, components with lot numbers, in-process checks, and the beyond-use date with its basis. Use when asked to document a compounded preparation, write a master formulation record, create a compounding worksheet, or prepare compounding documentation for inspection. Produces the master formula, the batch record, the component and lot table, in-process checks, labelling, and the beyond-use-date rationale. Documentation only; standards and stability data must come from current official references."
---

# Compounding Record

A compounding record has two readers: the person repeating the preparation next month, and an inspector asking how you arrived at a beyond-use date. Both need the same thing — the arithmetic visible, the components traceable to lot, and the reasoning written down rather than remembered. This produces a record that answers both without a phone call.

## What This Skill Produces

- **The master formulation record** — the reproducible formula, separate from any single batch
- **The batch record** — this preparation, with every calculation shown rather than just its result
- **A component table** — each ingredient with source, lot number, expiry, and quantity used
- **In-process checks** — what was verified during preparation, by whom, and at what point
- **Beyond-use date with its basis** — the date and the reference or data it derives from, which is what inspection asks about
- **The label and its required elements** — assembled against your jurisdiction's requirements

## Required Inputs

Ask for these if not provided:
- **The preparation** — final product, strength, dosage form, and total quantity
- **The formula** — ingredients and amounts, and the source of the formula
- **The components** — actual products used, with lot numbers and expiry dates
- **Equipment and environment** — what was used and where, including any controlled environment
- **The standards you work to** — your jurisdiction's compounding standard and the reference used for beyond-use dating

## Framework: Show the Arithmetic, Trace the Lot, Justify the Date

1. **Separate the master formula from the batch.** The master is the recipe and does not change; the batch is what happened today. Conflating them is the most common documentation failure.
2. **Write every calculation out.** Including the aliquot arithmetic and any potency or salt-form adjustment. A result without its working cannot be checked, and checking is the point.
3. **Have the calculation verified independently** where your standard requires it, and record who verified.
4. **Trace every component to a lot.** An ingredient without a lot number makes a recall impossible.
5. **Derive the beyond-use date, do not choose it.** State the reference or stability data it comes from. 'Thirty days' with no basis is the finding inspectors write up.
6. **Record the in-process checks as they happen.** Weight verification, appearance, pH, mixing time — at the point of the check, not reconstructed afterwards.

## Output Format

### Compounding record: [preparation] · [batch/Rx no.] · [date]

**MASTER FORMULATION RECORD**
Preparation: [name, strength, dosage form] · Source of formula: [reference]
| Ingredient | Amount per unit | Role |
|---|---|---|
| [ingredient] | [amount] | [active / vehicle / preservative] |
Equipment: [list] · Environment: [bench / controlled area, classification]

**BATCH RECORD**
Quantity prepared: [amount] · Prepared by: [name] · Date/time: [when]

**Calculations** — shown in full
```
[the working, step by step, including aliquots and any potency or salt-form adjustment]
```
Verified by: [second person, where required] · [date/time]

**Components used**
| Ingredient | Manufacturer/source | Lot | Expiry | Quantity used |
|---|---|---|---|---|

**In-process checks:** [weight verification · appearance · pH · mixing time — each with the result, who checked, and when]

**Final product:** appearance [description] · yield [actual vs theoretical] · **discrepancy investigated:** [if any]

**Beyond-use date:** [date] · **Basis:** [the reference, stability data, or standard relied on — cited]

**Label:** [product, strength, quantity, BUD, storage, prepared-by, batch number, and every element your jurisdiction requires]

> A documentation framework only. Compounding standards, permitted preparations, environmental requirements, verification rules and beyond-use dating are governed by your jurisdiction's official standards and must be taken from current official references — never from this template and never from recall. Sterile compounding carries requirements this structure does not attempt to cover.

## Quality Checks
- [ ] Master formula and batch record are separate documents
- [ ] Every calculation is written out, not just its result
- [ ] Independent verification is recorded where the standard requires it
- [ ] Every component has a lot number and expiry
- [ ] In-process checks were recorded at the time, with the checker named
- [ ] Actual yield is compared against theoretical, and any discrepancy is investigated
- [ ] The beyond-use date cites the specific basis it derives from

## Anti-Patterns
- **A result with no working.** Uncheckable, and the first thing an inspector asks to see.
- **Components without lot numbers.** Makes a recall impossible and is a serious finding.
- **A beyond-use date by habit.** '30 days' with no cited basis is written up every time.
- **Reconstructing in-process checks afterwards.** A check recorded later is not a check.
- **One document for formula and batch.** The recipe becomes unreproducible once it is entangled with a single day's numbers.
- **Ignoring a yield discrepancy.** An uninvestigated shortfall is the sign of an error nobody chased.

## Example Trigger Phrases
- "Write a compounding record for this suspension"
- "Create a master formulation record"
- "How do I document beyond-use dating for an inspection?"
- "We are being inspected — what should our compounding records show?"
- "Write a batch record with the calculations shown"