Watch the video - USP <797> Proposed Revision Update – Released September 1, 2021 Video in Module 1

CHECK YOUR UNDERSTANDING:

1. Which of the following best describes Immediate Use Compounding Category in the September 2021
Proposed Revision for USP <797>?
a. for emergent situations only, no PEC required
b. SOPs for training required
c. competency and aseptic technique
d. all the above are correct

2. Which of the following categories of compounding best describes compounding done in and ISO 5 PEC,
within an unclassified segregated compounding area (SCA) with BUD 12 hours at room temperature or 24
hours refrigerated?
a. Immediate Use Compounding
b. Category 1 Compounding
c. Category 2 Compounding
d. Category 3 Compounding

3. Which of the following compounding categories best describe compounding done in an ISO 5 PEC, within
a cleanroom suite, using sterile or nonsterile starting ingredients, sterility testing and sterilization
processes completed?
a. Immediate Use Compounding
b. Category 1 Compounding
c. Category 2 Compounding
d. Category 3 Compounding

4. Which of the following compounding categories best describe compounding in and ISO 5 PEC, CAN be the
same as Category 2 compounding but additional criteria before switching to this category; BUDs based on
sterility testing and applicable testing methods, extend up to 180 days.
a. Immediate Use Compounding
b. Category 1 Compounding
c. Category 2 Compounding
d. Category 3 Compounding

5. In the proposed <USP 797> BUD revision Limits for Category 2 CSPs what is the beyond use date for a CSP
that was Aseptically processed in a cleanroom suite where no sterility testing was performed and stored
in a controlled room temperature (20°-25°)
a. 45 days
b. 30 days
c. 10 days
d. 4 days
6. What is the BUD for a Category 2 CSP aseptically processed where sterility testing was performed and was
stored in 2°- 8° temperature?
a. 45 days
b. 10 days
c. 4 days
d. 1 day

7. Which of the following statement(s) best describe the September 2021 Proposed <USP 797> regarding
garbing, cleaning, and supplies requirement for Category 3 compounding?
a. No exposed skin in buffer room, sterile low-lint garb including gowns, gloves, head, face, and foot
coverings. Laundered garb must e re-sterilized
b. Weekly sporicidal use in PECs, work surfaces, pass throughs and floors
c. Work surfaces within the PEC and underneath the work tray weekly
d. All the above are correct.

8. Cleaning and disinfecting supplies within the PEC for all compounding categories applies to which of the
following statement(s)?
a. Passthrough and equipment inside the PEC weekly
b. Walls, doors, door frames, ceilings, storage shelving and bins, and equipment outside the PEC weekly
c. Work surfaces daily and all surfaces/underneath the work tray monthly
d. Work surfaces daily and all surfaces/underneath the work tray weekly

9. How often does compounding personnel undergo training and competency evaluations in core
compounding principles and skills?
a. Initially and every 12 months
b. Initially and every 6 months
c. Initially and every 3 months
d. Every 12 months

10. Under the new September 2021 <USP 797> proposed revision, how often must personnel undergo
demonstration and GFT with 0 CFUs for hand hygiene and Garbing?
a. Categories 1 and 2 – every 6 months
b. Category 3 – every 3 months
c. Categories 1, 2 and 3 – every 12 months
d. Both a and b are correct

11. Which of the following is true for hand hygiene and garbing personnel competency for Category 1 and
Category 2 compounding?
a. Ongoing competency for Category 1 and 2 every 6 months and Category 3 every 3 months
b. Ongoing competency for Category 1, 2 and 3 every 6 months
c. Ongoing competency for Category 1, 2 every 3 months and Category 3 every 6 months
d. Ongoing competency for Category 1, 2 and 3 every 3 months
12. Compounding personnel training and competency for aseptic technique requires which of the following?
a. Initial competency required prior to independent compounding including media fill, GFT and surface
sample (up to 3 CFU for both)
b. Ongoing competency every 6 months for Category 1 and 2
c. Ongoing competency every 3 months for Category 3
d. All the above are correct

13. What is the maximum BUD allowed for Category 3 terminally sterilized and frozen CSPs?
a. 10 days
b. 28 days
c. 45 days
d. 180 days

14. What is the maximum batch allowed for all CSPs requiring sterility testing?
a. 250 units
b. 100 units
c. 150 units
d. 500 units

15. What is the BUD for Multi-dose CSPs if antimicrobial effectiveness testing (USP <51>) is completed?
a. 4 days
b. 10 days
c. 28 days
d. 45 days

16. What is the BUD for Ophthalmic MDV only if prepared as Category 2 or 3 for a single patient?
a. 24 hours at room temperature
b. 72 hours refrigerated after opening
c. 1 hour at room temperature
d. 96 hours refrigerated after opening
e. Both a and b are correct

17. How often should environmental monitoring and surface sampling occur in the new Proposed USP <797>
Revision?
a. Categories 1 and 2: Monthly surface sampling, semi-annual air sampling
b. Category 3: Weekly surface sampling and at the end of each batch (within PEC); Monthly air sampling
and at least 30 days prior to commencing Category 3.
c. Monthly Categories 1, 2 and 3
d. Both a and b are correct

18. True or False: Keeping microbiologic identification is required only if results are out of limits.