Packaging, Labeling, and Documentation of CSPs Part 1 Flashcards
The Master ____ Record (MFR or FR) is a document that includes ingredients, preparation, and storage details of CSPs
Formulation
USP requires the following information to be included in the MFR: (7 answers)
Name, strength, dosage form
A physical description of the compound
All quantities and ingredients needed
Proper container
Complete instructions with steps, supplies, and equipment needed
Beyond-use dates (BUD) and storage requirements
Quality assurance (QA) processes for release testing (such as sterility testing and visual inspection)
A Compounding Record (CR) is completed by the compounder for every ____ prepared
CSP (or Compounded-Sterile Preparation)
USP requires the following information to be included on the CR:
Prescription or other assigned identification number given and preparer name
Name, strength, and dosage form
MFR reference (number) if used, or compounding preparation process details
Date and time of preparation with total prepared quantity compounded
Name of manufacturer, lot number, and expiration of each ingredient and container used
Weight or measurement of each ingredient
Calculations used to create quantities needed
Assigned BUD for CSP
QA procedures performed, such as visual inspection
Additional label for container if a batch is prepared