Packaging, Labeling, and Documentation of CSPs Part 1

Question 1

The Master ____ Record (MFR or FR) is a document that includes ingredients, preparation, and storage details of CSPs

Answer 1

Formulation

Question 2

USP requires the following information to be included in the MFR: (7 answers)

Answer 2

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)

Question 3

A Compounding Record (CR) is completed by the compounder for every ____ prepared

Answer 3

CSP (or Compounded-Sterile Preparation)

Question 4

USP requires the following information to be included on the CR:

Answer 4

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