USP 797

why revision needed

why revision needed

The revision to the BUD limits were established based on a risk-based approach since it is difficult to predict the stability and microbial susceptibility for all the different types of nonsterile and sterile preparations.

NEW concept

Water activity

water activity

assess the susceptibility of a nonsterile preparation to microbial contamination and the potent for degradation due to hydrolysis.

revised 797 - NON-preserved aqueous dosage form

14 days

revised 797 -Preserved aqueous dosage form =

35 days

revised 797 - NON-aqueous ORAL liquids =

90days

revised 797 - OTHER NON-aqueous dosage form =

180days

New factors for consideration when establishing BUDs

changed the categorization of compounded sterile preparations from microbial contamination levels to Category 1 and Category CSPs. Additionally, Category 3 CSPs were added.

Category 1 and 2:

distinguished based on the conditions under which they are made, the probability for microbial growth, and the period within which they must be used.

Category 1 VS category 2

• Category 1 = CSPs must be prepared in an ISO class 5 or better primary engineering control (PEC) that may be placed in an unclassified segregated compounding area (SCA) and have shorter BUDs

• Category 2 = CSPs must be prepared in a cleanroom suite and have longer BUDs.

Category 3

LONGER BUDs than the limits set for category 2 up to a maximum of 180days when compounded in accordance with all category 3 CSP requirements – undergo sterile testing, supplemented by endotoxin testing when applicable, more requirements than Category 2 – personal qualification, use of sterile garb, use of sporicidal disinfectants, frequency of environmental monitoring, and stability determination.

[T/F]

Longer BUD limits are permitted in certain specified circumstances based on additional requirements in engineering controls, environmental monitoring, and release testing.

TRUE

Category 1 - storage periods and BUD

• <_ 12 hours at CRT (Controlled Room Temperature)

• <_ 24 hours in a refrigerator

Category 2 - storage periods and BUDs

Aseptically processed, NO sterility testing, ONE or MORE NONSTERILE starting components

• 1 day at CRT

• 4 days in a refrigerator

• 45 days in a freezer

Category 2 - storage periods and BUDs

Aseptically processed, NO sterility testing, ONLY sterile stating components

• 4 days at CRT

• 10 days in a refrigerator

• 45 days in a freezer

Gowns wore during sterile compounding are considered a component of

PPE

Personal Protective Equipment

which USP chapter sets the legal standard for sterile compounding

a. USP 800

b. USP 700

c. USP 795

d. USP 797

D

The revised chapter USP 797 changed the categorization of compounded sterile preparations (CSPs) from microbial contamination risk levels (ex. low-, medium-, and high-risk level) [SELECT ALL]

a. category 1

b. category 2

c. category 3

d. category 4

A,B,C

According to USP category 1 compounded sterile products have a BUD at controlled room temperature of

LESS than 12 hours

The category CSPs that must be prepared in an ISO class 5 or better primary engineering control (PEC) that may be placed in an unclassified segregated compounding area (SCA) and have shorter BUDs is

Category 1

In the revised USP 797, additional requirements for

personnel qualification, use of sterile garb, use of sporicidal disinfectants, frequency of environmental monitoring, stability determination