Master Formulation / Compounding Record
Sterile Non-Hazardous Compounding <797>

Purpose/ Applicability:  To provide a guideline to establish appropriate documentation for the preparation of uniform formulations.

Scope: This applies to all CSPs.

Definition(s):

CSP: Compounded sterile product

USP: United States Pharmacopeia

MFR: Master Formulation Record

Equipment: N/A

Procedure:

Master Formulation

1. Formulas are developed by the pharmacist(s) and pharmacy technician(s)
   1. Formulas are then created following the template developed for a master formulation record
2. The name for the MFR should be unique and should identify the drug, strength, and dosage form of the product
3. The MFR must contain all information about the compounding process for the product
   1. It is used as a reference standard for preparing all batches of the CSP
4. The following details must be included on the MFR:
   1. Drug name
   2. Concentration
   3. Dosage
   4. Minimum quantity / Increments
   5. All included ingredients, math equations for ingredients
   6. Product description
   7. Instructions for compounding
   8. BUD and references
   9. Auxiliary labels, Dispensing information, Storage information

Compounding Record

1. Contains all of the above information as well as:
   1. Date created, Lot number
   2. NDC, Expiration, Manufacturer of each ingredient
   3. Amount of each ingredient with printed weights (from gm/mg)
   4. Completed equation section
   5. Signature of person preparing and signature of person checking
   6. Prescription label for individually compounded / dispensed product
   7. Filled out assessment of product section to confirm color, uniformity, quantity dispensed, correct BUD, etc.

Repackaging

1. Medications that come in large mL quantities can be repackaged into smaller vials or syringes as long as the proper policies and procedures are followed
2. BUDs should be determined by:
   1. 28 days since opened for vials
   2. The Pharmacist(s) based upon available studies for stability in plastic for syringes
   3. Sterility results from the VDL following repacking
3. Medications that are repackaged need to contain the appropriate information on each label
   1. Drug name
   2. Drug strength
   3. Lot #
   4. Expiration date
4. Vials that are repackaged need to have a sterile closure sticker placed on top
5. Syringes that are repacked need to have a sterile cap to close it properly prior to leaving the hood