What's The Difference?: Master Formulation Records and Compounding Records

MASTER FORMULATION
RECORDS AND
COMPOUNDING RECORDS:
What’s the difference?
The NAPRA Model Standards for Pharmacy Compounding of Non-sterile Preparations
require pharmacies to have policies and procedures as well as quality assurance
mechanisms in place to achieve the intended outcomes of enhancing patient safety and
protecting compounding personnel.
The gap analysis completed in the implementation The non-sterile compounding supervisor is
Phase 1 may have identified that the pharmacy needs responsible for ensuring that Master Formulation
to develop or update existing Master Formulation Records are developed, reviewed regularly and
Records in Phase 2. A Master Formulation Record updated as needed. When there are changes to the
includes all necessary information and appropriate record, compounding personnel must be informed.
procedures to safely compound a specific non-sterile The table below summarizes and compares the
preparation, whereas the Compounding Record is standards, guidance and content for these two types
generated every time that preparation is compounded of records. Please remember this is only a summary
with prescription- (or batch-) specific information that and the Guidance Document must be read and
must be verified before it is dispensed. interpreted as a whole.
STANDARDS AND GUIDANCE
MASTER FORMULATION RECORDS COMPOUNDING RECORD
Must be kept (in paper-based or electronic form) for each

Must be kept (in hard copy or electronic format) and be
individual prescription and for non-sterile preparations made
readily available to compounding personnel
in batches
These records should be filed and retained for future

Must be developed by regulated pharmacy personnel with
reference in accordance with the OCP Guidelines for Record
adequate experience and broad scientific knowledge
Retention
Must include all necessary information to compound the In cases where there is a marketed drug available, the
non-sterile preparation rationale for compounding should be documented in the
patient’s file with the appropriate justification
Must be based on scientific data and contain supporting In cases where the preparation was compounded by another
rationale and references pharmacy in accordance with a Central Fill agreement, this
should be recorded
Should be kept together Allow for auditability and traceability, be able to track
information related to preparations in the event of a recall
Must be current and reviewed yearly or when new As part of the quality assurance process, this should be
information becomes available reviewed quarterly
PAGE 20 ~ WINTER/SPRING 2021 ~ PHARMACY CONNECTION

MASTER FORMULATION RECORDS AND COMPOUNDING RECORDS
SUMMARY OF CONTENT
MASTER FORMULATION RECORD COMPOUNDING RECORD
Official or assigned name of the preparation
Strength and dosage form of the preparation
Calculations needed to determine and verify quantities of Names and quantities of ingredients used, and calculations
ingredients for quantity produced performed (if applicable)
Description of ingredients, their quantities and sources (e.g.,

Sources, lot numbers and expiry dates of ingredients
physical description, DIN, manufacturer, etc.)
Expected yield Total quantity compounded
Compatibility and stability data, including any supporting Assigned BUD

documentation and references used to determine the beyond-
use date (BUD) Assigned preparation batch number or prescription number
Reference to Master Formulation Record (including any devia-

Source or origin of the formula* tions)
• References used to develop the formula
• Date last reviewed and/or updated
Date of compounding the preparation
Special precautions to be observed

Name of the person who compounded the preparation
• Personal protective equipment (PPE)
Name of the person who approved/verified the preparation
• Any specialized training for a specific procedure
Description of final preparation Results of quality control procedures

• Name of the person who performed the quality control
procedures
Quality control procedures and expected results (e.g., weight • Documentation of any quality control issues and any adverse
range of filled capsules, pH of aqueous liquids, etc.) reactions or preparation problems reported by the patient
Equipment needed to compound the preparation (and any special

cleaning instructions)
* There may be formulations for compounded preparations

Mixing instructions and methods, which may include:
available in the public domain or for purchase. When
• order of mixing
considering the use of pre-existing formulations, the
• mixing temperatures or other environmental controls
Non-Sterile Compounding Supervisor is responsible for
• duration of mixing
ensuring that NAPRA standards for the Master Formulation
• other factors pertinent to consistent replication of the prepara-
Record are met and that they are suitable for the conditions
tion
and circumstances of the pharmacy’s practice, by assessing,
modifying, adapting and/or updating them as necessary.
Packaging and storage requirements
• Type of container used in dispensing
•Sample label
Since there are similarities between the content of College is not directive in how the requirements of
the Master Formulation Record and Compounding the Standards are met, and it is up to the pharmacy to
Record, some pharmacies may use a copy of the develop policies and procedures taking into account
Master Formula as a basis for the Compounding the systems and technology they have in place.
Record. Also, a prescription’s dispensing record
created may also serve as an outline for the ADDITIONAL REFERENCES
Compounding Record, if the information required by
Printable and Fillable template for a Master
the Drug and Pharmacies Regulations Act, s156(1) is
Formulation Record (NAPRA)
suitable for meeting what is required by NAPRA. The
PHARMACY CONNECTION ~ WINTER/SPRING 2021 ~ PAGE 21

What's The Difference?: Master Formulation Records and Compounding Records

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MASTER FORMULATION

STANDARDS AND GUIDANCE

MASTER FORMULATION RECORDS COMPOUNDING RECORD

Must be kept (in paper-based or electronic form) for each

These records should be filed and retained for future

PAGE 20 ~ WINTER/SPRING 2021 ~ PHARMACY CONNECTION

MASTER FORMULATION RECORD COMPOUNDING RECORD

Official or assigned name of the preparation

Strength and dosage form of the preparation

Description of ingredients, their quantities and sources (e.g.,

Expected yield Total quantity compounded

Compatibility and stability data, including any supporting Assigned BUD

Reference to Master Formulation Record (including any devia-

Special precautions to be observed

Description of final preparation Results of quality control procedures

Equipment needed to compound the preparation (and any special

* There may be formulations for compounded preparations

PHARMACY CONNECTION ~ WINTER/SPRING 2021 ~ PAGE 21

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* There may be formulations for compounded preparations