Can pharmacy technicians prepare nonsterile compounds?
Pharmacy technicians are an integral part of the sterile compounding process and are regularly responsible for preparation of compounded sterile products (CSPs). High risk compounded sterile products (CSPs) are often made from non-sterile components and require sterilization prior to administration to patients.
What are the minimum attire standards for non-sterile compounding?
Personnel involved in compounding haz- ardous materials should wear safety goggles, gloves, a mask or respirator, double gowns, and foot covers as required, depending on the substance being handled.
How frequently should non-sterile compounding personnel be assessed for competency?
Equipment and devices used in the compounding or testing of compounded preparations must be inspected prior to use and, if appropriate, verified for accuracy as recommended by the manufacturer and at the frequency recommended by the manufacturer, or at least every 12 months, whichever is more frequent.
What is non-sterile manufacturing?
Non-sterile compounding are medications made in a clean environment that’s not completely free from all microorganisms. This type of compounding is for drugs to be taken orally or topically.
Which preparation is an example of moderate non-sterile compounding?
Examples of moderate non-sterile compounding (non-inclusive): mixing two or more commercially manufactured creams, ointments, or liquids when the stability of mixture is unknown (i.e. Magic or Miracle Mouthwash) topical preparations intended for local effects.
How many risk levels are associated with compounded sterile preparations CSPs )?
USP 797 assigns each CSP one of five potential contamination risk levels: immediate use, low, low with 12 hours or less beyond use date (BUD), medium, high. The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP.
What is the most important aspect of PPE in regard to non-sterile compounding?
For compounders doing non-sterile applications without any hazardous drugs the garment worn as PPE is really protecting the preparation being compounded and the clean environment. USP Chapter <795> provides limited information on the required garments but includes the use of hair covers, masks and gloves.
What is one of the three components of a non-sterile compound?
Kienle: Chapter <795> defines the three parts of a nonsterile compound as the active pharmaceutical ingredient (API), inactive ingredients, and the diluent or vehicle. Accordingly, the beyond-use date (BUD) of the final product cannot exceed the expiration date of any of its individual components.
Why does the law assume the risk to public health is low with nonsterile compounding?
Why does the law assume the risk to public health is low with nonsterile compounding? Compounders are not involved in mass production. OSHA & NIOSH. Which of the following components is covered by the standards of the USP Good Compounding Practices?
What are some advantages of non sterile compounding?
What are the advantages of non-sterile compounding? customizable options available with non-sterile compounding are: Custom-made strength or dosage: Commercially available products come in a set range of doses, meaning you may be getting more or less of the medication than your body needs.
What is the difference between sterile and non sterile?
When there is an absence of microorganisms in a procedure kit, it is deemed as sterile. A non-sterile kit protects the patient against pathogenic microorganisms such as in the use of custom trays.
Which preparation is a simple non-sterile compounded product?
Examples of Simple Non-Sterile Compounding: Captopril Oral Solution, Indomethacin Topical Gel, and Potassium Bromide Oral Solution. Moderate Non-Sterile Compounding: Compounding a preparation that requires special calculations or procedures to determine quantities of components per preparation or per dosage unit.