Which Master Formulation Record fields do USP ⟨795⟩ and ⟨797⟩ list?

MFR vs compounding record — recipe vs this-batch log

The Master Formulation Record is the recipe for that prep type. You write it before you compound. It says how this shop makes that cream, capsule, or CSP — not what happened on Tuesday’s batch.

The Compounding Record is this-batch log. It says what you actually did this time: who compounded, when, which lots, the quantity of each component (you fill the number), and whether that run followed the MFR.

You need both. A recipe with no batch log is a plan nobody proved. A batch log with no recipe is a one-off you cannot repeat or defend.

The registry lists this answer under USP 797 so it sits on the sterile chapter hub. The copy is a 795 / 797 overlay. Do not treat the 797 badge as a sterile-only table.

Educational only. Not legal advice. Not a substitute for your licensed USP text or PIC judgment. Not a promise about any inspection outcome.

• MFR = the recipe for that prep type.
• CR = this-batch log — what you actually did.
• Both chapters use that split. Confirm the exact wording in licensed ⟨795⟩ and ⟨797⟩.

Most of this page is not rule-set grounded

Say this out loud: PharmacyCompounding.AI’s cited rule set only has a handful of Master Formulation Record and Compounding Record rules. Most of the field names on this page are chapter-cited only — not rule-set grounded.

The one line we can treat as rule-backed here is revised ⟨797⟩ 11.2: a compounding record when an immediate-use CSP is prepared for more than one patient. The MFR and compounding-record field names below are chapter-cited from ⟨795⟩ Box 7-1 and ⟨797⟩ Box 9 (and related sections). Confirm every field in your licensed chapter. Do not treat this page as if our rule set already covers every line.

Public NABP inspection blogs later on this page are culture / surveyor signal only. They are not hearing cites and not a citation rate.

• Thin rule set on Master Formulation Record and Compounding Record lines.
• Most fields here are chapter-cited only, not rule-set grounded.
• Rule-backed on this page: ⟨797⟩ 11.2 compounding record when an immediate-use CSP is prepared for more than one patient.
• Your licensed USP text, SOP, and board still own the official list.

MFR field names (chapter-cited shape)

These are field names USP chapters list. They are chapter-cited, not backed by our thin rule set. Leave them blank until your pharmacist fills them. If a line would be a clinical decision on a real MFR, it does not belong here as a filled example.

Confirm the official wording in licensed ⟨795⟩ Box 7-1 (nonsterile) and ⟨797⟩ Box 9 (sterile). Do not copy a sterile line onto a nonsterile jar, or the other way around.

• Name, strength, and dosage form of the prep type — field names only. This page does not fill a strength or concentration.
• Physical description of the finished prep — what it should look like when it is done. You write the description.
• Identity of each component / ingredient — names of what goes in, not example amounts.
• Quantity of each component — a named blank. This page does not fill an amount.
• Complete compounding instructions — the steps, not a vendor card you never finished.
• Quality-control procedures — name the method. ⟨795⟩ Box 7-1 also includes expected results (you fill the result). ⟨797⟩ Box 9 includes quality-control procedures; do not invent a 797 expected-results field. Confirm Box 9 in licensed text.
• Beyond-use date plus the reference that supports that BUD — chapter table, monograph, or stability package as the source type. The date alone is not the source. This page does not assign a BUD.

Compounding-record field names (chapter-cited shape)

The compounding record is this batch, not the recipe. These are field names the chapters list for this-batch logs — chapter-cited, not rule-set required. Fill the values on the live log — not from this page.

Confirm the official CR list in licensed ⟨795⟩ and ⟨797⟩. Chapter wording differs.

• Date and time of compounding.
• Identity of who compounded.
• Identity of who checked or reviewed — your SOP says who.
• Which Master Formulation Record this batch used.
• Identity and lot of each component used.
• Quantity of each component used — a named blank. This page does not fill a number.
• Total quantity compounded — a named blank.
• Physical description of this batch’s finished prep.
• Quality-control results for this batch.
• BUD assigned to this batch, plus storage.
• Attestation that this batch followed the MFR — and a stop when it did not.

795 nonsterile vs 797 sterile — and immediate-use

USP ⟨795⟩ uses the same two-document idea for nonsterile work (CNSPs): an MFR for each prep type, a compounding record for each batch. USP ⟨797⟩ uses it for sterile work (CSPs).

QC fields differ by chapter. ⟨795⟩ Box 7-1 includes quality-control procedures and expected results. ⟨797⟩ Box 9 includes quality-control procedures. Confirm Box 9 wording in licensed text — do not copy the 795 expected-results line onto a sterile MFR.

Immediate-use is about how fast that CSP is used and which controls apply. Revised ⟨797⟩ 11.2 requires a compounding record when an immediate-use CSP is prepared for more than one patient. Confirm single-patient and other exceptions in licensed text. Do not treat “we used it right away” as a blanket skip, and do not treat “never skip MFR/CR” as a cleared rule.

Chapter details differ. Do not copy a sterile field list onto a nonsterile jar, or the other way around. Confirm each chapter in licensed text.

• ⟨795⟩ = nonsterile recipe + this-batch log. QC procedures and expected results (Box 7-1).
• ⟨797⟩ = sterile recipe + this-batch log. QC procedures (Box 9) — confirm licensed wording; do not invent expected results.
• Immediate-use: CR when prepared for more than one patient (⟨797⟩ 11.2). Confirm single-patient / other exceptions in licensed text.

What inspectors still talk about — culture / surveyor signal only

Public NABP inspection blogs still talk about incomplete MFRs and compounding records. That is culture / surveyor signal only — not a citation rate and not a cite you can take to a hearing. Confirm what your inspector and your board actually ask.

NABP, 4 Dec 2024 — common deficiencies: https://nabp.pharmacy/news/blog/nabp-compounding-pharmacy-inspections-identify-common-deficiencies/

NABP, 13 Aug 2025 — common findings: https://nabp.pharmacy/news/blog/common-findings-from-nabp-pharmacy-inspections/

Those write-ups keep returning to the same missing field names: physical description, complete instructions, quality-control procedures, the reference that supports the BUD, and a compounding record that shows the batch followed the MFR. A vendor recipe card, purchased formula, or software template is a starting point. It is not automatically a complete MFR.

• NABP blogs = culture / surveyor signal. Not a hearing cite.
• The field names they keep naming match the chapter boxes above. Confirm licensed text.
• A vendor recipe is not automatically a complete MFR.

How this differs from SOP binders and BUD dating pages

Your SOP binder is how the pharmacy runs — training, cleaning, QA, who may compound. It is not the recipe for one cream or one CSP.

The related inspection-prep page is the systems folder: designated person, training files, certification, records. Pull it when you are staging the walk-through — not when you need to know whether this formula has the chapter-listed fields.

The related USP 795 BUD page is dating and throw-out timing — how long you may keep a nonsterile compound, and when to discard it. This page is MFR/CR field shape: did the recipe and this-batch log have the fields, and did the live compound follow the MFR?

Do not use a BUD table as a stand-in for a complete MFR. Do not use a complete MFR as a stand-in for the dating clock.

• This page = MFR/CR field names (recipe + this-batch log).
• BUD discard page = dating / throw-out timing.
• Inspection-prep page = systems evidence. SOP binder = how the shop runs.

Practical bench check before the next batch

Before you start the next batch, pull the MFR — not the vendor PDF in someone’s inbox. Point to the field. Do not copy a filled example from this page onto a real record.

This is a bench habit, not a statute checklist. Confirm the official fields in licensed USP text and your SOP.

• Can you point to a physical description of the finished prep?
• Can you point to the identity of each component — without inventing an amount from this page?
• Can you point to complete compounding instructions?
• Can you point to the QC procedures? On a ⟨795⟩ MFR (Box 7-1), can you also point to the expected results? Do not invent an expected-results field for ⟨797⟩ Box 9.
• Can you point to the BUD and the reference that supports it?
• Does the compounding record have named blanks for this-batch lots, quantities, QC results, and a place to show this batch followed the MFR?
• If you are working from a vendor recipe, has this shop turned it into a complete MFR?
• Immediate-use for more than one patient: can you point to the compounding record (⟨797⟩ 11.2)? Confirm single-patient and other exceptions in licensed text.

State / SOP overlay — verify licensed chapter

Your board may adopt a different USP edition or add documentation lines. Your SOP can be stricter than the chapter. The official field list lives there — not in a remembered vendor card.

Ask Compounding AI Pro with the actual MFR and last compounding record for a cited starting point. Start Free Demo if you are not in the product yet. You still verify the licensed chapter, the current master SOP, and your board.

• Licensed USP ⟨795⟩ and ⟨797⟩ text first — including immediate-use if that is the path.
• Current master compounding SOP second.
• State board overlays third — including a different adopted edition.

FAQ

Does a vendor recipe count as our MFR?

No — not automatically. A purchased formula, vendor card, or software template is a starting point. You still need the fields your licensed USP chapter and SOP list. Educational only.

Does immediate-use skip the MFR and compounding record?

Not as a blanket yes. Revised ⟨797⟩ 11.2 requires a compounding record when an immediate-use CSP is prepared for more than one patient. Confirm single-patient and other exceptions — including whether an MFR is required — in licensed text. Educational only.

Is the BUD on the label enough, or does the MFR need the source too?

The label BUD is the date staff use. The MFR still needs the BUD plus the reference that supports it. The related 795 BUD page covers dating and throw-out timing — this page is whether that source field is on the record. Confirm licensed text.

Will you give example strengths or quantities we can copy?

No. This page lists field names. Concentrations, strengths, and quantities for a given prep are your clinical decisions. A named blank is in scope. A filled example is not.

Who signs the MFR vs the compounding record?

Your SOP and licensed chapter say who authorizes the MFR when it is created or changed, and who completes and reviews the compounding record for this batch. A common shop pattern is pharmacist / designated-person authorization on the MFR and compounder plus reviewer on the CR. Confirm locally — this page does not name the signature line as statute.

Related

• usp-795-nonsterile-bud-discard
• usp-797-inspection-prep-checklist
• usp-compounding-designated-person-annual-duties