Lecture 2-3: USP 797

Question 1

USP chapter 797 applies to who?

Answer 1

All persons who prepare CSP and all places where CSPs are prepared for human/animal patients

Question 2

USP 797 are standards for what?

Answer 2

preparing compounded sterile medications

Question 3

USP 797 ensures

Answer 3

patient benefit
reduces risk of contamination, infection, or incorrect dosing

Question 4

Does USP have a role in enforcement?

Answer 4

No, they are only standards of care

Question 5

Who is responsible for ensuring compliance with the requirements of the standards?

Answer 5

State boards of pharmacy (able to enforce by law)

Question 6

Designated person

Answer 6

Required by USP 797
1 or more individuals responsible/accountable for performance/operation
Qualifications determined by facility’s SOPs

Question 7

Types of CSP

Answer 7

Immediate use
Category 1
Category 2
Category 3

Question 8

CSP type influences:

Answer 8

Personnel training/competency
garbing requirements
air sampling
certification/recertification
BUD

Question 9

Compounding of sterile prep that does not happen in the pharmacy

Answer 9

Immediate use CSP

Question 10

Immediate use CSP

Answer 10

normal room “bedside”
- follow aseptic technique, SOP in place
- trained and demonstrate competency
- DONT use more than 3 different sterile products
- ok to use multiple of the same product

Question 11

How soon do you have to use a prep prepared via immediate use CSP

Answer 11

Must begin within 4 hrs following start of prep

Question 12

What can you do if CSP prepared at bedside is not used immediately?

Answer 12

label names and amount of active ingredients
label name/initials of preparer
4 hr time by which administration must begin

Question 13

Compounding of sterile prep that occurs in the pharmacy

Answer 13

Category 1,2,3 CSPs

Question 14

Category 1 CSP

Answer 14

prepared in ISO class 5 or better PEC
may be placed in unclassified SCA (outside of cleanroom)
- shorter BUD
- used to prepare in shorter time frame

Question 15

Category 2 CSP

Answer 15

prepared in a cleanroom suite

Question 16

Category 3 CSP

Answer 16

Undergo sterility testing
+ endotoxin testing when applicable
More requirements:
- personnel qualification
- sterile garb
- frequency of sporicidal disinfectants
- frequency of environmental monitoring
- stability determination

Question 17

Beyond Use Dating

Answer 17

Hour and Date after which a CSP may not be used, stored, transported
Influenced by storage conditions and CSP types

Question 18

CSP assigned a BUD based on storage at RT ___ moved to a refrigerator or freezer to extend original BUD

Answer 18

CANT

Question 19

Longer BUDs permitted with additional requirements

Answer 19

Engineering controls
Environmental monitoring
Release testing

Question 20

BUD of in-use stock solutions

Answer 20

12 hours max

Question 21

In stock solution

Answer 21

diluted solution that can have doses drawn off for many different patients throughout the hospital

Question 22

BUD administration ______ covered by USP 797

Answer 22

Not covered, based on different organizations

Question 23

Hang time (administration)

Answer 23

the time during which CSP may be infused before tubing or medication must be changed

Question 24

Can you infuse a drug 1-hr before BUD, but is ordered to infuse over 2 hours?

Answer 24

yes, infusion over BUD is fine, just need to start infusing before the BUD

Question 25

IV push

Answer 25

rapid administration seconds to minutes

Question 26

IV intermittent

Answer 26

small volumes infused over a specific amount of time (minutes-hrs)

Question 27

IV piggyback

Answer 27

medication administered via secondary IV tubing connected to the primary tubing

Question 28

IV continuous

Answer 28

infusion of meds over hours to days using electronic infusion device Drips IV fluids, TPN/lipids

Question 29

Examples of medications given

Answer 29

Pressors pain/sedation NMJ blocker insulin diuretics

Question 30

Compounding continuous infusions considerations

Answer 30

Diluent Concentration Final product

Question 31

Diluents

Answer 31

should be standardized, must consider IV compatability Exceptions may apply (if keto, prep in NS rather than D5W)

Question 32

Concentration

Answer 32

Specific to central VS peripheral administration Should be specific to the institution

Question 33

Final product

Answer 33

Syringe or IV bag dependent on institution and infusion device

Question 34

Staff training and competency

Answer 34

1. Visual observation of hand hygiene and garbing 2. Gloved fingertip and thumb sampling 3. Media fill testing

Question 35

Gloved fingertip/thumb sampling

Answer 35

Measures both the microorganisms and particles in the controlled compounding environment/surfaces Reveals poor aseptic technique/improper disinfection of sterile gloves

Question 36

Media fill testing (process simulation)

Answer 36

Critical microbiological test carried out to assess aseptic technique Work with sterile culture media instead of drug product ex: Ask to perform a series of manipulations using aseptic technique, the growth media that you worked with was incubated & inspected after certain amount of time for growth

Question 37

You must have a master formulation record for:

Answer 37

All CSPs prepared from non-sterile ingredients CSPS prepared for multiple patients

Question 38

You must have a compounding record for:

Answer 38

CSP 1,2,3 Immediate use CSP for multiple patients

Question 39

What counts as a compounding record?

Answer 39

Prescription Medication order Label

Question 40

Can compounding record be stored electronically?

Answer 40

Yes, required information is retrievable

Question 41

Viable environmental sampling frequency

Answer 41

Required 1. Viable air sampling 2. Surface sampling (CSP area)

Question 42

What is no longer covered in USP 797

Answer 42

Provisions for handling hazardous drugs (800) Provisions for radiopharmaceuticals (825)