USP General Chapter <795>

Lectures 3 and 4

As per USP <795>, the label of the CNSP must be verified to ensure that it conforms with the following:

Prescription or medication order, Master Formulation Record, and Compounding Record

As per USP <795>, BUD limit for nonaqueous topicals (aw < 0.60) in the absence of a USP−NF Compounded Preparation Monograph or CNSP-specific stability information is

180 days

Upon receipt of a component, the ______ must be reviewed to ensure it has met the acceptance criteria specified in the appropriate USP–NF monograph, if one exists.

COA

When establishing a BUD for a compounded preparation, which of the following should NOT be considered?

The cost of the ingredients used in the preparation

Which of the following statements about the selection of an Active Pharmaceutical Ingredient (API) for compounding, as per USP <795>, is correct?

Must have a Certificate of Analysis (COA) showing specifications and test results meeting expected quality

Which of the following statements about Quality Assurance (QA) and Quality Control (QC) in nonsterile compounding is NOT correct?

QA/QC programs do not need to be documented in the facility’s Standard Operating Procedures (SOPs)

As per USP <795>, what is the BUD for a nonpreserved aqueous dosage form (aw > 0.60) when it is stored in a refrigerator?

14 days

Which of the following statements about water activity (aw) and its impact on Beyond-Use Dates (BUDs) is correct?

Nonaqueous dosage forms have low water activity and therefore typically have longer BUDs

What is the primary purpose of USP General Chapter <795>?

To establish standards for the preparation of compounded nonsterile preparations (CNSPs)

Which of the following statements about the minimum frequency for cleaning and sanitizing work surfaces in nonsterile compounding areas, as per USP <795>, is NOT correct?

Work surfaces must be cleaned and sanitized only once per week if no visible contamination is present

Which of the following statements best describes the difference between a Beyond-Use Date (BUD) and an expiration date?

A BUD is determined by most pharmacists using USP guidelines, while an expiration date is based on manufacturer stability testing

Which of the following must be included on the label of a compounded nonsterile preparation (CNSP) only if applicable?

Storage conditions

Which of the following statements is NOT correct? As per USP <795>, a compounded nonsterile preparation (CNSP) must be visually inspected upon completion of compounding and before it is released and dispensed.

To determine the strength of the CNSP

What is the primary responsibility of the designated person(s) in a facility’s QA/QC program for nonsterile compounding?

Overseeing adherence to procedures, investigating quality issues, and conducting annual QA/QC reviews

Which of the following statements about a master formulation record (MFR) and a compounding record (CR), as per USP <795>, is correct?

A CR must be created for all compounded nonsterile preparations