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
- 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.
- 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.
- Have the calculation verified independently where your standard requires it, and record who verified.
- Trace every component to a lot. An ingredient without a lot number makes a recall impossible.
- 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.
- 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
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"
1---2name: compounding-record3description: 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.4---5
6# Compounding Record
7
8A 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.
9
10## What This Skill Produces
11
12- **The master formulation record** — the reproducible formula, separate from any single batch
13- **The batch record** — this preparation, with every calculation shown rather than just its result
14- **A component table** — each ingredient with source, lot number, expiry, and quantity used
15- **In-process checks** — what was verified during preparation, by whom, and at what point
16- **Beyond-use date with its basis** — the date and the reference or data it derives from, which is what inspection asks about
17- **The label and its required elements** — assembled against your jurisdiction's requirements
18
19## Required Inputs
20
21Ask for these if not provided:
22- **The preparation** — final product, strength, dosage form, and total quantity
23- **The formula** — ingredients and amounts, and the source of the formula
24- **The components** — actual products used, with lot numbers and expiry dates
25- **Equipment and environment** — what was used and where, including any controlled environment
26- **The standards you work to** — your jurisdiction's compounding standard and the reference used for beyond-use dating
27
28## Framework: Show the Arithmetic, Trace the Lot, Justify the Date
29
301. **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.
312. **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.
323. **Have the calculation verified independently** where your standard requires it, and record who verified.
334. **Trace every component to a lot.** An ingredient without a lot number makes a recall impossible.
345. **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.
356. **Record the in-process checks as they happen.** Weight verification, appearance, pH, mixing time — at the point of the check, not reconstructed afterwards.
36
37## Output Format
38
39### Compounding record: [preparation] · [batch/Rx no.] · [date]
40
41**MASTER FORMULATION RECORD**
42Preparation: [name, strength, dosage form] · Source of formula: [reference]
43| Ingredient | Amount per unit | Role |
44|---|---|---|
45| [ingredient] | [amount] | [active / vehicle / preservative] |
46Equipment: [list] · Environment: [bench / controlled area, classification]
47
48**BATCH RECORD**
49Quantity prepared: [amount] · Prepared by: [name] · Date/time: [when]
50
51**Calculations** — shown in full
52```
53[the working, step by step, including aliquots and any potency or salt-form adjustment]
54```
55Verified by: [second person, where required] · [date/time]
56
57**Components used**
58| Ingredient | Manufacturer/source | Lot | Expiry | Quantity used |
59|---|---|---|---|---|
60
61**In-process checks:** [weight verification · appearance · pH · mixing time — each with the result, who checked, and when]
62
63**Final product:** appearance [description] · yield [actual vs theoretical] · **discrepancy investigated:** [if any]
64
65**Beyond-use date:** [date] · **Basis:** [the reference, stability data, or standard relied on — cited]
66
67**Label:** [product, strength, quantity, BUD, storage, prepared-by, batch number, and every element your jurisdiction requires]
68
69> 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.
70
71## Quality Checks
72- [ ] Master formula and batch record are separate documents
73- [ ] Every calculation is written out, not just its result
74- [ ] Independent verification is recorded where the standard requires it
75- [ ] Every component has a lot number and expiry
76- [ ] In-process checks were recorded at the time, with the checker named
77- [ ] Actual yield is compared against theoretical, and any discrepancy is investigated
78- [ ] The beyond-use date cites the specific basis it derives from
79
80## Anti-Patterns
81- **A result with no working.** Uncheckable, and the first thing an inspector asks to see.
82- **Components without lot numbers.** Makes a recall impossible and is a serious finding.
83- **A beyond-use date by habit.** '30 days' with no cited basis is written up every time.
84- **Reconstructing in-process checks afterwards.** A check recorded later is not a check.
85- **One document for formula and batch.** The recipe becomes unreproducible once it is entangled with a single day's numbers.
86- **Ignoring a yield discrepancy.** An uninvestigated shortfall is the sign of an error nobody chased.
87
88## Example Trigger Phrases
89- "Write a compounding record for this suspension"
90- "Create a master formulation record"
91- "How do I document beyond-use dating for an inspection?"
92- "We are being inspected — what should our compounding records show?"
93- "Write a batch record with the calculations shown"
Mohit Aggarwal