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Questions and Answers on USP 797
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A1 Question: What is
USP Chapter 797?
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A2 Question: How do I
get a copy of USP Chapter 797?
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A3 Question: Does USP
Chapter 797 provide all I need to know about compounding
sterile preparations?
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A4 Question: What is a
"compounded sterile preparation" according to USP
Chapter 797?
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A5 Question: Is USP
Chapter 797 applicable just to pharmacies that compound
sterile products?
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A6 Question: Are
enforceable sterile compounding standards necessary?
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Answer
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A7 Question: What
can I do now to meet the requirements of USP Chapter 797?
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Answer
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E1 Question:
Our inpatient
pharmacy recently purchased Barrier Isolators. What are
the clean room
guidelines with these in place? I keep getting
conflicting information and would like to not have to do
a lot of rework.
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Question E2:
I am a Pharmacy Operation Manager at a Children’s
Hospital. I am attempting to provide justification of
extending storage periods of certain medium-risk batched
CSPs. My understanding is that if sterility testing is
performed, storage periods can be extended up until the
expiration dates of the ingredients being used. I am
wondering if sterility testing needs to be performed on
each batch or if the process itself can be verified as
aseptic. In our situation, we have an automated pump
that will produce 10ml saline-flush syringes from a
2000ml bag. Other than the set up of the machine, there
is no human involvement in the process. To determine
sterility, we would conduct a media fill test by pumping
media fill from a bag into syringes and then verify
sterilty by determining if there is bacterial growth.
We would also do a one time set of tests to determine
the sterility of the saline flushes. We would send
several samples of the batch to the lab and have them
tested for sterility over a period of several
days/weeks. We would periodically (quarterly) repeat
the media fill test on the pump to recheck the aseptic
process, but we would not continue to check the batches
of saline syringes for sterility. We would assume that
if the pump continues to produce sterile media fill
syringes that it would also continue to produce sterile
saline syringes.
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E3 Question:
I have been contacted by several vendors selling
services that relate to complying with 797 regs. The
latest outfit claimed that according to new 797
regulations effective Jan 1st 2008, that all
Chemotherapy preparation done in a vertical flow
biohazard cabinet must be done in a completely different
clean room with a separate ante area from our regular
clean room and ante area. Is this true or is this hype
to get me to subscribe to their service. Also, what is
the best way to know the regulations and comply with
them?
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Answer
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E4 Question:
I am inquiring
if there is any information that is listed in the USP
797 guidelines that limit's the on floor hang time of
Intralipid emulsions not drawn up but dispensed in
original bag? I have recently heard through colleagues
that due to USP 797 practices that Intralipid in the
original bag is only allowed to hang for 12 hours no
longer once hung on the set on the floor. I
am trying to figure out if this is a USP 797 requirement
or if it is a suggestion from the manufacturer. If
you could please send me any information you have
on this subject I would greatly appreciate it.
Thank you for your time.
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Answer
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E5 Question:
In reviewing the literature, both past
and present USP 797 materials, I have come across the
following:
Assuming opened:
- Expiration of multidose vials should not exceed 30
days.
- All multidose vials should discarded after 28 days.
- All multidose vials should be discarded after 30 days
except for insulin and vaccines.
- Insulin should have a 28 days expiration
- Vaccines can, if properly stored, be used for the
length of the expiration date on the bottle.
- What is the consensus on expiration dating of opened
multidose vials, including insulin and vaccines?
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Answer
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E6 Question:
What are the fines or penalties for non compliance to
usp 797 regulation?
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Answer
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E7 Question: What the status of revisions is to
USP 797. I am most particularly interested in issues
relating to environmental sampling. Are multiple media
required? Are settle plates to be discontinued in lieu
of slit-to-agar samplers? If so, is there guidance on
the sample volume and flow rate of the samplers? Are
contact plates to be discontinued?
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Answer
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E8 Question:
I was looking for more info on Hot Labs in Nuclear
Medicine departments. Will they be affected by USP
797?
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Answer
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E9
Question:
Are there any temperature guidelines that apply for 797?
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Answer
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E10
Question:
Can
hazardous drugs (chemotherapy) and compounded items be
mixed in the same biological safety cabinets?
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Answer
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E11
Question: Our clients are hearing rumors that the
required full implementation schedule for USP 797 is no
longer 1/1/08 but has been moved back. Is this true?
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Answer
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E12
Question:
What
are the current Joint Commission requirements for
implementation? Are the requirements approved by
the State of Texas Board of Pharmacy?
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Answer
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E13
Question: When wiping down a laminar flow hood, are
there any specifications as to the type of wipes that
are allowed?
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Answer
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E14
Question:
I work at military hospital in an outpatient oncology
clinic. Currently we schedule our patients for lab work
wait on the results and then dependent upon the results
of the labs we administer the chemotherapy. We the
nurses, have always mixed the chemo ourselves in a
sterile environment. We mix the chemotherapy and
immediately (immediately meaning <1-2 minutes after
preparation) administer it to the patients. Does USP 797
apply to our situation? This is becoming a very big
debate at our facility.
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E15 Question:
When
wiping down a laminar flow hood, are there any
specifications as to the type of wipes that are allowed?
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Question B1: Sterile
Compounding Personnel - Does USP 797 apply only to
pharmacy personnel?
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Question B2: Sterile
Compounding Personnel - Should pharmacy personnel remove
all jewelry and makeup before entering the buffer zone,
even if jewelry or makeup is covered by masks, gloves or
goggles?
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Question B3: Sterile
Compounding Personnel - Should pharmacy personnel garb
if they must come and go frequently from the buffer
room, such as when they make STAT doses?
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Answer
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Question B4: Sterile
Compounding Personnel - Our sterile compounding
personnel watch a video and take a test annually. Do
they also need to perform media fill testing?
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Answer
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Question B5: Low-Risk
Compounding - Does USP 797 apply to nurses or others who
prepare a sterile dose for immediate administration to a
patient?
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Question B6: Low-Risk
Compounding -What is meant by time of storage periods
versus time of administration?
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Question B7: Low-Risk
Compounding -Would USP 797 apply to irrigations,
ophthalmic or otic preparations, immunization syringes
drawn up in batch, anesthesiology medications drawn up
in advance, and baths and soaks for live organs and
tissues?
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Question B8:
Medium-Risk Compounding - Does risk level move up a
notch if storage time is exceeded?
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Answer
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Question B9: High-Risk
Compounding - Does every high-risk compounded sterile
product (CSP) have to be sterility tested and
quarantined before use?
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Question B10: High-Risk
Compounding -Does the potency of every high-risk
preparation have to be determined?
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for Answer
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Question B11: Clean
Rooms - Is there scientific proof that clean rooms
prevent infections?
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Question B12: Clean
Rooms - What is the scientific evidence of the need for
sterile garb (e.g., gowns, gloves, masks, goggles)?
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for Answer
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Question B13: Clean
Rooms - If admixtures are made within a LAFW, why does
its location matter?
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Question B14: Clean
Rooms - If the LAFW is already in a separate room, do
you really need a cleanroom?
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Question B15: Clean
Rooms - If pharmacy-prepared admixtures have never been
implicated in nosocomial infections, why should sterile
preparation practices and facilities be upgraded?
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for Answer
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Question B16: Clean
Rooms - Isn't good aseptic technique more important than
a clean room in preventing microbial contamination?
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for Answer
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Question
B17: Clean Rooms -
Since building a cleanroom is so expensive, why not
return the responsibility for admixture preparation to
nurses?
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Question B18: Clean
Rooms - Can a computer, refrigerator, or freezer be
located in a cleanroom?
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Question B19: Clean
Rooms - Is a tile floor acceptable in an anteroom or
buffer room?
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Question B20: Clean
Rooms - Does JCAHO expect pharmacy to have a cleanroom
(i.e., a buffer room) in place when we are surveyed in
the Spring of 2005?
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Question B21: Clean
Rooms - Does a biological safety cabinet (BSC) have to
be located in a negative pressure room?
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for Answer
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Question B22: Barrier
Isolators -Does an isolator have to be located in a
buffer room?
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Question B23:
Compounded Sterile Preparation Environment -Can CSPs
returned unused from patient rooms be re-used (i.e., is
microbial contamination of the anteroom or buffer room
the issue)?
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Question B24:
Compounded Sterile Preparation Environment -Why should a
vial or ampul removed from an outer box be sanitized
before it is passed from the anteroom to the buffer
room?
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Question B25: Cleaning
and Sanitizing Workspaces - Does isopropyl alcohol used
for cleaning and disinfecting workspaces have to be
sterile?
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Question B26:
Environmental Monitoring - If settling plates are used
to monitor for microbes, is particulate air sampling
still required?
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Question B27:
Environmental Monitoring - If air particulates are
monitored, is temperature and humidity monitoring still
required?
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Question B28: Equipment
- As long as we follow manufacturer's instructions, what
else is required to use equipment, apparatus, and
devices in sterile compounding?
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for Answer
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Question B29: Equipment
- How should one verify the accuracy on automated
compounding devices (ACD) for parenteral nutrition (PN)
compounding?
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Question B30: Storage
and Beyond Use Dating - What is the difference between
an expiration date and a beyond-use date?
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Here for Answer
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Question B31:
Maintaining Product Quality and Control after the CSP
Leaves the Pharmacy - Assuming that pharmacy spikes a
chemotherapy admixture with a set before it leaves the
pharmacy, what safeguards should pharmacy make?
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for Answer
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Question B32: Packing
and Transporting Compounded Sterile Preparations - We
are an "outsourcing pharmacy" compounding admixtures for
local hospitals. What safeguards are needed for
packaging and transport to hospitals?
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for Answer
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Question B33: Hazardous
Drug Handling - Our Class II BSC is not vented to the
outside. Is this acceptable?
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