Sterile Compounding:
On January 1, 2004 USP (United states Pharmacopeia – a book describing drugs, chemicals, and medicinal preparations in United States) issued guidelines for manipulation of a sterile or nonsterile product intended to produce a sterile final product known as USP 797.
What is USP 797?
It is the first enforceable sterile preparation compounding standard.
• Purpose – patient safety
• Applies to healthcare institutions, pharmacies, physician practice facilities, and other facilities in which compounded sterile preparations (CSPs) are prepared, stored, and dispensed
• Pertains to all pre-administration manipulations of compounded sterile preparations, CSPs, including preparation, storage, and transport.
• Includes preparation according to manufacturer’s labeled instructions.
Why Sterile Compounding?
Customize strength or dosage.
Flavor a medication (to make it more palatable for a child or a pet).
Reformulate the drug to exclude an unwanted, nonessential ingredient, such as lactose, gluten, or a dye to which a patient is allergic.
Change the form of the medication for patients who, for example, have difficulty swallowing or experience stomach upset when taking oral medication.
Sterile compounded medications are intended to be used as injections, infusions, or application to the eye.
Common Sterile compound – Atropine Eye drops:
Atropine 1% is the commercially available strength of atropine eyedrops which is used for pupil dilation, to relieve pain and any inflammation. Our pharmacy is equipped with the sterile compounding cleanroom to formulate the lower dilution of Atropine eyedrops in 0.01% – 0.05% to treat myopia. The 0.01% strength has been proven to show fewer side effects and the best effectiveness for myopia control.
Have questions about compounds? Call us at 703-522-3412 and ask to speak to a pharmacist.
