For Potency and Purity:
•We use only the highest quality USP Pharmaceutical grade
powders
• Lot traceability along with Certificates of Analysis and
MSDS documentation on all powders
•Pedigree on all powders is on file
•Highest standard for potency testing available
•All powders weighed to within 1/1000 of a gram and electronically
recorded for date, time, manufacturer, lot number, expiration date,
and staff ID
For Sterility
•We test preparations for sterility both in house and with
an independent analytical lab
•Daily documented routine for cleaning and testing all surfaces
•We use a state of the art class 1000 clean room with class
100 laminar flow hoods
•We use an on going lot sampling protocol for quality assurance
testing that exceeds recommended standards
•All staff are certified for Aseptic compounding
•All preparations exceed the FDA guidelines for Endotoxins
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Exceeding Quality Standards:
"The United States Pharmacopoeia (USP) recently
released procedures and requirements for compounding sterile preparations.
General chapter <797>, titled “Pharmaceutical Compounding
– Sterile Preparations,” states that sterile compounding procedures
require clean facilities, specific training for operators, air quality
evaluations, and a sound knowledge of sterilization and stability principles.
The nature of defining how these preparations shall be manufactured is
related to the potential risk to patients should errors occur.(1)"
The USP chapter 797 guidelines set the standard for sterile
compounding procedures. At RxNations, we not only meet current standards,
we exceed them. With over 30 years of compounding without a single incident,
our commitment to providing the highest level of quality service shows
for itself.
Risk Level Three Compounding:
This is the most demanding form of preparation
that a compounding pharmacy can formulate, and we have been doing it longer
than any active pharmacy. We are not the largest compounding pharmacy
in the business, nor do we aspire to be. We just want to be the best.
Starting with our method of testing our preparations, we distinguish ourselves
by the fact that our testing is performed both in-house as well as by
an independent laboratory. This redundancy gives us more checks, and greater
confidence in our quality preparations. Our test methodology is more accurate
than HPLC testing, and is recommended by the FDA over HPLC methods, further
separating us from other Compounding Pharmacies.
Particulates Inspection
This important step in the assurance of a high quality preparation is
performed both in house using USP 788 guidelines and at an independent
analytical laboratory. This redundancy further reinforces our commitment
to deliver quality sterile preparations.
(1) Source: http://www.usp797.org
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Patients: Do you suffer from hot flashes, dry
skin, mood swings, or other symptoms of menopause
or PMS? Would you like to attend a FREE
seminar on how you can take control of your health? Check
our calendar to find out when there will be a presentation in your area, or
sign up for our newsletter below.
Physicians:
Can't Find what you're looking for? RxNations can create a custom compound just
for you! We offer a free consultation
service to get your patients the medications they need. Featured Products:
Mibolerone (veterinary) Formerly known
as "Cheque Drops" it is a compounded contraceptive used
extensively in show dogs and by breeders for the prevention of estrous
or the lengthening of the inter-estrous interval, the time between
a dogs heat.
Call Us Today!
352-597-4950
Toll Free:
1-800-752-7139
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