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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

 

 

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

Patients:
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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.

 

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352-597-4950

Toll Free:
1-800-752-7139