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Quality and Safety
Precision Pharmacy has assembled a professional team that
has been brought together to ensure that quality and safety are
our top priority. We have an intense compounding training program
to make sure that all of the members of our team are knowledgeable
and properly trained to effectively communicate with our patients
and other healthcare practitioners.
Before you choose a compounding pharmacy, you should feel comfortable
with the answers to the following questions:
- Do you have a sterile compounding license issued by the California
state board of pharmacy? (One of the most discriminating pharmacy
licenses in the nation)
- Do you have beyond use dates on compounded medications that
are in line with the united states pharmacopoeia suggesting and
not longer those 6 months on any compounded preparation?
- Do you perform sterility testing on every compounded sterile
preparation?
- Do you have a class 10,000 clean room with a class 100 biological
safety hood?
- Do you have an independent certified auditor come into your
clean room to certify it at least 2 times per year?
- Do you regularly perform environmental monitoring in high risk
compounding areas?
- Do you perform daily monitoring and reporting on temperature
in all vital compounding and storage areas?
- Is your staff properly trained and tested in aseptic technique,
clean room gowning, hand washing, and general clean room use?
- Is your biological safety cabinet cleaned before and after each
use and before the day starts and at the end of the day?
- If there is a discrepancy in a sterility test, do you have a
system in place to investigate the source of the problem?
- Are sterile preparations guaranteed until it is determined to
be sterile from an incubation test unless otherwise noted?
- Is ph testing done on indictable and sterile preparations to
determine if they are within proper guidelines?
- Do you perform hplc analysis on random, compounded batches from
an independent laboratory?
- Do you have adequate liability insurance that covers the preparations
that are compounded in your pharmacy?
- Do you purchase your chemicals from only FDA approved suppliers?
- Are certificates of analysis available on all ingredients used
in your preparations?
- Can you trace each ingredient used in your formulations back
to the original lot #, supplier, and origin?
- Are the formulations with which you compound tested in labs
by professional consultants and chemists with results/findings
that show stability and expected potency?
- Is the equipment used in compounding properly calibrated on
a regular schedule to ensure proper values and weights?
- Are all steps that are taken to compound medications either
supervised or done by a registered pharmacist?
- Are your pharmacists and staff constantly updating their data
base and knowledge of compounding through education and classes?
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