Sterile Preparations include:
- Intravenous injections and admixtures
- IM, SC, and Epidural (preservative-free) injections
- Erectile dysfunction injections
- Ophthalmic preparations
- Discontinued or unavailable medications
USP Chapter 797 has established a new national standard for sterile compounding preparations, including compounding, transportation and storage; and requires that all pharmacy compounding personnel be adequately educated, instructed, and skilled to perform their functions.
The goal of USP Chapter 797 is to protect patients from harm associated with contaminated or improperly prepared compounded sterile preparations. At Buderer Drug Co., we follow all 797 sterile compounding requirements.
We utilize an independent laboratory and QI Medical in-house testing to test our compounded sterile preparations for endotoxins, potency, and sterility. Our sterile compounding equipment is certified by an independent company on a bi-annual basis, and our personnel are certified in aseptic technique.
Examples of Sterile Products provided by Buderer Drug Co.:
- Intrathecal pump medications: e.g., morphine, fentanyl, clonidine, hydromorphone, bupivacaine, Prialt, etc.
- Sodium Tetradecyl Sulfate, straight chain injection, various strengths and other customized sclerosing solutions. (Note: the commercial preparation is a branched chain injection.)
- Phentolamine, papaverine, prostaglandin injections, various strengths, also known as Bi-mix, Tri-mix and Quad-mix injection.
- Cardioplegia solutions, Buckbergs reperfusate solutions, various strengths
Compounding for Retina Specialists: Bevacizumab (Avastin®) Injection
Anterior Chamber Injections: Injections may contain: Ceftazidime, Vancomycin, Dexamethasone, Triamcinolone, Hydrocortisone, etc. in a balanced salt solution base.
Fortified Antibiotic or Antifungal Drops: Fortified Ceftazidime, Fortified Vancomycin, Fortified Gentamicin or Tobramycin, Fortified Cefazolin, Fortified Amphotericin, Fortified Voriconazole.
Specialized Eye Dilating Office Procedure Drops: Customized solutions may contain any of the following: Phenylepherine HCl, Tropicamide, Cylopentolate HCl, Tetracaine HCl, Lidocaine HCl, Ciprofloxacin, Ofloxacin.
Miscellaneous Ophthalmic Formulations: Blood serum, PHMB, Propamidine Isethionate, DHEA, Hyaluronidase, Mitomycin, EDTA and Preservative-Free formulas.
This list is not all-inclusive. Please call our compounding pharmacists for more options!
Tour our Sterile Compounding area.
Compounding laboratory for sterile preparations.
Our ISO Class 7 cleanroom offers a complete, floor-to-ceiling physical barrier that completely controls our environment, with an ISO Class 5 Laminar flow hood and ISO Class 7 Glove-box. An autoclave, depyrogenating oven, and Isotech barrier isolation unit optimize sterility of compounded preparations.
Our ISO Class 7 cleanroom offers a complete, floor-to-ceiling physical barrier that completely controls our environment, with an ISO Class 5 Laminar flow hood and ISO Class 4 Glove-box. An autoclave, depyrogenating oven, and Isotech barrier isolation unit optimize sterility of compounded preparations.
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