BCSCP PREP QUESTIONS AND ANSWERS
The intent of 797 chapter to prevent harm, including death from what five risks? - CORRECT
ANSWER✅✅✅1) microbial contamination [nonsterility],
2) excessive bacterial endotoxins,
3) variability from the intended strength of correct ingredients, 4) physical and chemical
incompatibilities,
5) chemical and physical contaminants, and/or
6) use of ingredients of inappropriate quality.
USP 797 2022 EM excursion investigational requirements (5 listed)? - CORRECT ANSWER✅✅✅1.
Investigate, take corrective action, and review effectiviness.
2. Corrective action plan based on CFU # & microorganism.
3. Extent of investigation based on deviation.
4. Document corrective action plan.
5. ID growth to genus if ID exceeded (microbiologist assist).
**No more mention of "highly pathogenic organisms"**
Viable Air Sampling Frequency USP 797 2022 - CORRECT ANSWER✅✅✅Category 1 and Category 2
CSPs, this must be completed at
least every 6 months.
Category 3 CSPs, this must be completed within 30 days prior to the commencement of any Category 3
compounding and at least monthly thereafter regardless of the frequency of compounding Category 3
CSPs.
USP 797 (2022) provides guidance on the number of units required to be sterility tested for smaller
batches, what is the number of units that meet this requirement and how many units need to be tested?
If the the number of units are greater what guidelines need to be followed? - CORRECT
ANSWER✅✅✅If batch is 1-39 units then 10% rounded to the next whole number may be tested.
If 40 or more units require sterility testing then refer to tables 2 and 3 in USP 71.
,According to USP 797 (2022) which CSPs are required to have endotoxin testing? - CORRECT
ANSWER✅✅✅CSP that are compounded from nonsterile ingredients and are assigned a BUD date
that requires sterility testing.
Category 3 BUD date must be supported by what type of stability data? What are the four elements of
stability requirements according to USP 797 (2022) - CORRECT ANSWER✅✅✅Stability data using a
stability-indicating method (SIM), that distinguishes active ingredients from degradants and impurities.
Four elements:
1. Exact formulation from which stability data is derived.
2. Same storage & container closure material composition as study.
3. Validated analytical method as described in <1225>
4. Facility must have documentation of study, including methodology, validation of method, SIM and
results.
What conditions if any can a BUD be extended past those listed in the tables of USP 797 (2022)? -
CORRECT ANSWER✅✅✅Cannot be extended based on SIM performed by organization or peer
reviewed literature.
Can be extended based on based on USP-NF monograph if followed exactly with tests that are required.
Beyond-Use-Date (BUD) as described in USP 797? How is this time determined? - CORRECT
ANSWER✅✅✅The date, or hour and the date, after which a CSP must not be used, stored, or
transported.
BUD is determined by the date and time from which the CSP compounding started.
When is preparation of conventionally manufactured product considered out of scope of USP 797
(2022)? (name 3 requirements) - CORRECT ANSWER✅✅✅1. Prepared as a single dose.
2. For a single patient.
3. Approved labeling specifies the diluent, the resultant strength, the container closure system, and the
storage time.
What are the 5 factors described in USP 797 (2022) that affect microbial risk? - CORRECT
ANSWER✅✅✅1. Conditions of environment where CSP is prepared.
2. Aseptic processing and sterilization method.
,3. Starting components.
4. Sterility testing.
5. Storage conditions.
When are Point-of-care systems (like addEASE, ADD-Vantage, Mini-Bag Plus) considered out of scope
and when are they considered in scope of USP 797 (2022)? What determines BUD dates when they are
in scope? - CORRECT ANSWER✅✅✅Out of scope when docked and activated for immediate
administration according to manufacturer instructions.
In scope when docked for future activation and administration - considered compounding and must
follow 797 except for BUD dates which default to manufacturer's labeling.
What is the longest permitted BUD for Category 1? What environment can Category 1 be compounded?
- CORRECT ANSWER✅✅✅Controlled Room Temperature (20°-25°) <=12 h, Refrigerator
(2°-8°) <= 24h. SCA or Cleanroom suite.
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared from one or more
NONSTERILE starting component(s), when sterility testing is NOT performed? - CORRECT
ANSWER✅✅✅Controlled Room Temperature (20°-25°): 1 day
Refrigerator (2°-8°): 4 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared from only STERILE
starting component(s), when sterility testing is NOT performed? - CORRECT
ANSWER✅✅✅Controlled Room Temperature (20°-25°): 4 days
Refrigerator (2°-8°): 10 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared, when sterility testing
is performed and passed? - CORRECT ANSWER✅✅✅Controlled Room Temperature (20°-25°): 30
days
Refrigerator (2°-8°): 45 days
Freezer (−25° to −10°): 60 days
, What are the longest permitted BUDs for Category 2 CSPs that have been terminally sterilized, but
sterility testing is NOT performed? - CORRECT ANSWER✅✅✅Controlled Room Temperature (20°-
25°): 14 days
Refrigerator (2°-8°): 28 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs that has been terminally sterilized and a
sterility testing is performed and passed? - CORRECT ANSWER✅✅✅Controlled Room Temperature
(20°-25°): 45 days
Refrigerator (2°-8°): 60 days
Freezer (−25° to −10°): 90 days
What are the longest permitted BUDs for Category 3 CSPs that has been ASEPTICALLY processed,
sterility tested, and passing all applicable tests for Category 3 CSPs? - CORRECT
ANSWER✅✅✅Controlled Room Temperature (20°-25°): 60 days
Refrigerator (2°-8°): 90 days
Freezer (−25° to −10°): 120 days
What are the longest permitted BUDs for Category 3 CSPs that has been terminally sterilized, sterility
tested, and passing all applicable tests for Category 3 CSPs? - CORRECT ANSWER✅✅✅Controlled
Room Temperature (20°-25°): 90 days
Refrigerator (2°-8°): 120 days
Freezer (−25° to −10°): 180 days
ISO 5, 7, 8 Particle requirements and sample volumes? - CORRECT ANSWER✅✅✅Limits 0.5 µm and
larger per m3, ISO 5: 3,520; ISO 7: 352,000; ISO 8: 3,520,000. Minimum of 1 minute sample time and 2
liter volume of air.
Sterilizing Grade Membrane Requirement - CORRECT ANSWER✅✅✅Retain 100% of cultures of 10^7
Brevundimonas (Pseudomonas) diminuta /sq cm of surface under not less 30 psi (1 bar). 0.2-0.22 µm
The intent of 797 chapter to prevent harm, including death from what five risks? - CORRECT
ANSWER✅✅✅1) microbial contamination [nonsterility],
2) excessive bacterial endotoxins,
3) variability from the intended strength of correct ingredients, 4) physical and chemical
incompatibilities,
5) chemical and physical contaminants, and/or
6) use of ingredients of inappropriate quality.
USP 797 2022 EM excursion investigational requirements (5 listed)? - CORRECT ANSWER✅✅✅1.
Investigate, take corrective action, and review effectiviness.
2. Corrective action plan based on CFU # & microorganism.
3. Extent of investigation based on deviation.
4. Document corrective action plan.
5. ID growth to genus if ID exceeded (microbiologist assist).
**No more mention of "highly pathogenic organisms"**
Viable Air Sampling Frequency USP 797 2022 - CORRECT ANSWER✅✅✅Category 1 and Category 2
CSPs, this must be completed at
least every 6 months.
Category 3 CSPs, this must be completed within 30 days prior to the commencement of any Category 3
compounding and at least monthly thereafter regardless of the frequency of compounding Category 3
CSPs.
USP 797 (2022) provides guidance on the number of units required to be sterility tested for smaller
batches, what is the number of units that meet this requirement and how many units need to be tested?
If the the number of units are greater what guidelines need to be followed? - CORRECT
ANSWER✅✅✅If batch is 1-39 units then 10% rounded to the next whole number may be tested.
If 40 or more units require sterility testing then refer to tables 2 and 3 in USP 71.
,According to USP 797 (2022) which CSPs are required to have endotoxin testing? - CORRECT
ANSWER✅✅✅CSP that are compounded from nonsterile ingredients and are assigned a BUD date
that requires sterility testing.
Category 3 BUD date must be supported by what type of stability data? What are the four elements of
stability requirements according to USP 797 (2022) - CORRECT ANSWER✅✅✅Stability data using a
stability-indicating method (SIM), that distinguishes active ingredients from degradants and impurities.
Four elements:
1. Exact formulation from which stability data is derived.
2. Same storage & container closure material composition as study.
3. Validated analytical method as described in <1225>
4. Facility must have documentation of study, including methodology, validation of method, SIM and
results.
What conditions if any can a BUD be extended past those listed in the tables of USP 797 (2022)? -
CORRECT ANSWER✅✅✅Cannot be extended based on SIM performed by organization or peer
reviewed literature.
Can be extended based on based on USP-NF monograph if followed exactly with tests that are required.
Beyond-Use-Date (BUD) as described in USP 797? How is this time determined? - CORRECT
ANSWER✅✅✅The date, or hour and the date, after which a CSP must not be used, stored, or
transported.
BUD is determined by the date and time from which the CSP compounding started.
When is preparation of conventionally manufactured product considered out of scope of USP 797
(2022)? (name 3 requirements) - CORRECT ANSWER✅✅✅1. Prepared as a single dose.
2. For a single patient.
3. Approved labeling specifies the diluent, the resultant strength, the container closure system, and the
storage time.
What are the 5 factors described in USP 797 (2022) that affect microbial risk? - CORRECT
ANSWER✅✅✅1. Conditions of environment where CSP is prepared.
2. Aseptic processing and sterilization method.
,3. Starting components.
4. Sterility testing.
5. Storage conditions.
When are Point-of-care systems (like addEASE, ADD-Vantage, Mini-Bag Plus) considered out of scope
and when are they considered in scope of USP 797 (2022)? What determines BUD dates when they are
in scope? - CORRECT ANSWER✅✅✅Out of scope when docked and activated for immediate
administration according to manufacturer instructions.
In scope when docked for future activation and administration - considered compounding and must
follow 797 except for BUD dates which default to manufacturer's labeling.
What is the longest permitted BUD for Category 1? What environment can Category 1 be compounded?
- CORRECT ANSWER✅✅✅Controlled Room Temperature (20°-25°) <=12 h, Refrigerator
(2°-8°) <= 24h. SCA or Cleanroom suite.
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared from one or more
NONSTERILE starting component(s), when sterility testing is NOT performed? - CORRECT
ANSWER✅✅✅Controlled Room Temperature (20°-25°): 1 day
Refrigerator (2°-8°): 4 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared from only STERILE
starting component(s), when sterility testing is NOT performed? - CORRECT
ANSWER✅✅✅Controlled Room Temperature (20°-25°): 4 days
Refrigerator (2°-8°): 10 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs ASEPTICALLY prepared, when sterility testing
is performed and passed? - CORRECT ANSWER✅✅✅Controlled Room Temperature (20°-25°): 30
days
Refrigerator (2°-8°): 45 days
Freezer (−25° to −10°): 60 days
, What are the longest permitted BUDs for Category 2 CSPs that have been terminally sterilized, but
sterility testing is NOT performed? - CORRECT ANSWER✅✅✅Controlled Room Temperature (20°-
25°): 14 days
Refrigerator (2°-8°): 28 days
Freezer (−25° to −10°): 45 days
What are the longest permitted BUDs for Category 2 CSPs that has been terminally sterilized and a
sterility testing is performed and passed? - CORRECT ANSWER✅✅✅Controlled Room Temperature
(20°-25°): 45 days
Refrigerator (2°-8°): 60 days
Freezer (−25° to −10°): 90 days
What are the longest permitted BUDs for Category 3 CSPs that has been ASEPTICALLY processed,
sterility tested, and passing all applicable tests for Category 3 CSPs? - CORRECT
ANSWER✅✅✅Controlled Room Temperature (20°-25°): 60 days
Refrigerator (2°-8°): 90 days
Freezer (−25° to −10°): 120 days
What are the longest permitted BUDs for Category 3 CSPs that has been terminally sterilized, sterility
tested, and passing all applicable tests for Category 3 CSPs? - CORRECT ANSWER✅✅✅Controlled
Room Temperature (20°-25°): 90 days
Refrigerator (2°-8°): 120 days
Freezer (−25° to −10°): 180 days
ISO 5, 7, 8 Particle requirements and sample volumes? - CORRECT ANSWER✅✅✅Limits 0.5 µm and
larger per m3, ISO 5: 3,520; ISO 7: 352,000; ISO 8: 3,520,000. Minimum of 1 minute sample time and 2
liter volume of air.
Sterilizing Grade Membrane Requirement - CORRECT ANSWER✅✅✅Retain 100% of cultures of 10^7
Brevundimonas (Pseudomonas) diminuta /sq cm of surface under not less 30 psi (1 bar). 0.2-0.22 µm
