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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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E16 Question:
Have you heard of any decision by NYS board of Pharmacy
with regard to compliance with USP 797?
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E17 Question:
I work for a regional health system in Texas. We have
just opened the Occupational Health Center which will be
providing occupational health to the hospital employees;
as well as, the local community, industry, etc. One of
the services that we will be providing is travel health,
including immunizations. This is where the question
arises. The hospital currently has a policy that
multi-dose vials of medications should be dated and
discarded on the 29th day; however, the CDC guidelines
indicate that immunizations are good through the
expiration date on the multi-dose vial once opened. The
hospital here is struggling with this issue and how to
properly store immunizations. Many immunizations come
in multi-dose vials and are very expensive. To open a
multi-dose vial of immunization that costs $700+ and
then only be able to keep for 30days would not be cost
effective for the hospital, nor could you reasonably
pass the cost of the possible loss on the patient.
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E18 Question:
I am a hospital pharmacist that has been put in charge
of 797 for my institution. I have a copy of the
proposed changes, but have not heard anything about them
being changes in 797. I am currently basing all of my
decision on the USP 28, but like some of the proposed
changes. When will the proposed changes become the new
797?
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E19 Question:
Is there a temperature guideline to meet 797 compliance
in the clean room?
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E20 Question:
When will the final USP 797 guideline be done? I was
under the understanding that this was to be done January
07, but I have not seen anything as of yet.
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E21 Question:
We agree in our hospital for the beyond use dating of
syringes of Dopamine etc that have been pulled out of
the pre made manufacturer bags. Our question is how long
can the syringe be hung for once the RN starts the drip?
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E22 Question:
We have several clerkships where sterile compounding is
a part of the clerkship. These clerkships are six weeks
in length. There are some people recommending that
students who go these clerkships should perform a media
fill and complete a written exam two weeks before the
start of the clerkship. They already do this as part of
the compounding course that they take in their second
year. However, by the time they are ready to go these
clerkships, that certification has expired. How does USP
797 apply to experiential education? Are these students
who are there for a short period of time considered
"pharmacy personnel"?
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E23
Question: Q: In your "Question and Answer" website
it states:
"In the official version of USP Chapter <797>, effective
January 1, 2004 the following language can be found: If
multiple-dose parenteral medication vials (MDVs) are
used, refrigerate the MDVs after they are opened unless
otherwise specified by the manufacturer. Discard the
MDVs when empty, when suspected or visible contamination
occurs, or when the manufacturer's stated expiration
date is reached, provided the manufacturer's storage
conditions have been adhered to. Expiration dating not
specifically referenced in the package insert should not
exceed 30 days once the vial has been opened."
In the in-process revision of the USP Chapter <797>, the
PROPOSED language can be found: Multiple-dose
containers (e.g., vials) are formulated for removal of
portions on multiple occasions because they contain
antimicrobial preservatives. The beyond-use date after
initially entering or opening (e.g., needle-punctured)
multiple-dose containers is 28 days (see Antimicrobial
Effectiveness Testing <51>), unless otherwise specified
by the manufacturer.
If the vial is labeled as a multidose vial or container
then the dating should not exceed 28 days UNLESS the
manufacturer has data to support longer dating."
My question: Will the in-process revision of the USP
Chapter <797> (29 day limit) apply to all MDVs, whether
from a manufacturer (e.g., Alcon, Allergan) or CSPs from
a pharmacy?
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E24
Question:
We are
a small critical access hospital with no pharmacist here
daily; just a consultant who comes weekly. We have a
contract with another pharmacy to mix our TPN. Can the
nurses add any medications to TPN? We do not have a
hood.
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E25
Question:
Are there any guidelines regarding the commonly used 10%
rule? (i.e. if adding an additive to a base fluid where
the additive’s volume exceeds 10% of the volume of the
base fluid, the additive’s volume is first withdrawn
from the base fluid, before the additive is added).
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E26
Question: I am a pharmacist here in Texas and I am
working on updating our policies on UPS 797. Can you
tell me the main differences between 2007 and 2008? I do
understand that they will be effective by June 2008.
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E27
Question: Can you please tell me exactly what has
changed from the 2008 version from the 2007 version?
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E28
Question:
The majority of our extracts ... indicate expiration
dates on the multidose vials. Once the vials are opened
and stored
appropriately according to manufacturer, does the 28 day
discard policy
still apply?
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E29
Question:
I am a pharmacist working for a Clinical Research
Organization. The CRO has always contracted out pharmacy
services, and has just now hired me to be a full time in
house pharmacist. I would like to know what we are
required to have in order to be current with USP 797
standards.
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E30
Question:
I’m working in a warehouse with controlled temperature
and we have a little problem with this control. We have
4 temperatures chambers now, and they are: Ambient (8 to
30 ºC), Cold (2 to 8 ºC), Freezer (-20 to -30 ºC) and
Ultra-Freezer (<-65ºC). The equipments works well
enough, but (sometimes) there is a little excursion and
this is a great problem to solve it.My question is: Is
there any USP Standard data about excursions of these
ranges? We are looking for something similar to this for
each range: “Standard cold room is between 2 & 8ºC, but
excursions between 0 and 15ºC up to 12 hours are
allowed”.
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E31
Question:
Q: Does USP797 apply to radiopharmaceuticals used in
Nuclear Medicine?
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E32
Question:
We make LET solution to be used topically to numb the
skin. I am trying to determine if this falls under the
USP 797. We do sterilize it and use more than 3
ingredients. But would this be considered "high risk"
CSP if it is topical?
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E33
Question:
Simple
scenario of a nurse spiking a plain commercially
available bag of IV fluid (eg NS) in a non-ISO 5
environment (eg OR suite, medication room, etc).
How long can the infusion bag be hung assuming
controlled room temperature?
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