Category 1 CSPs

Question 1

What are the Category 1 CSP beyond-use dates (BUD)?

Answer 1

Less than 12 hours at room temperature

Less than 24 hours if kept in the refrigerator

Question 2

What does BUD mean?

Answer 2

Beyond-use date

Question 3

What are the Category 1 CSP Environmental control requirements?

Answer 3

Can be compounded in a segregated compounding area (SCA)

Or, a classified area that includes a separated ISO Class 7 and 8 area

Question 4

What does SCA mean?

Answer 4

segregated compounding area

Question 5

The SCA must be located away from traffic flow and any unsealed windows or outside doors. The area must contain an ISO Class 5 ____ (PEC).

Answer 5

primary engineering control

Question 6

What are the Category 1 CSP Personal hygiene and protective equipment requirements?

Answer 6

Adhere to the requirements for garbing and handwashing.

Visual check is performed at least quarterly.

Question 7

Gloved fingertip/thumb sampling performed ____

Answer 7

quarterly

Question 8

Medication vials and supplies used to compound must be away from the ____.

Answer 8

PEC

Question 9

Only trained personnel should enter ____

Answer 9

SCA

Question 10

The environment for Category 1 CSPs needs to be ____ by an independent, qualified person

Answer 10

certified

Question 11

PEC within the SCA must be certified by an outside organization at least every six months. Tests to complete: (5 answers)

Answer 11

Airflow testing
High-efficiency particulate air (HEPA) filter integrity
Total particle counts
Smoke studies
Surface sampling

Question 12

Surface sampling must be required ____

Answer 12

monthly