What is a Category 1 compound?

Category 1 CSPs are defined as “CSP that is assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less refrigerated that is compounded in accordance with all applicable requirements for Category 1 CSPs in this chapter.” Category 1 CSPs may be prepared in an unclassified Segregated Compounding …

What is CSP risk level?

The appropriate risk level—low, medium, or high—is assigned according to the corresponding probability of contaminating a CSP with (1) microbial contamination (microbial organisms, spores, and endotoxins) and (2) chemical and physical contamination (foreign chemicals and physical matter).

What is Category 3 CSP?

Category 3 CSPs are those that may be assigned longer BUDs than the limits for Category 1 or Category 2 CSPs, up to 180 days, if additional requirements are met.

What are Category 1 compounded sterile products?

Category 1 CSPs are preparations that are compounded in a segregated compounding area, which consists of an ISO 5 primary engineering control—such as a laminar-airflow workbench—that is located outside of an ISO 7 clean room.

What is the difference in BUDs between Category I and Category II?

Category 1: CSPs are typically prepared in an unclassified Segregated Compounding Area (SCA) and have shorter BUDs. Category 2: CSPs are prepared in a cleanroom suite and have longer BUDs.

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.

What is low risk level?

Low Risk This is the second lowest level of risk. Although marginally more serious than Minimal Risk encounters, Low Risk patients are generally quite healthy.

Can medium risk and high risk CSPs be mixed for immediate use?

Medium-risk and high-risk CSPs cannot be mixed for immediate use.

What is Category I and Category II CSPs?

Category 1 CSPs are compounded in an ISO 5 primary engineering control (such as a laminar-airflow workstation) that is located in a segregated compounding area. Category 2 CSPs are compounded in an ISO 5 primary engineering control that is located in an ISO 7 buffer area.

How many risk levels exist under the USP 797?

five potential
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.

How many risk levels are associated with compounded sterile preparations CSPs )?

How hard is it to pass BUDs?

They are tough but not bad, if you prepare properly. The two-mile ocean swims are not bad, either, if you are used to swimming with fins when you arrive. The obstacle course will get you, too, if you are not used to climbing ropes and doing pull-ups. Upper body strength is tested to the max.

How much sleep do you get in BUDs?

“It’s very, very difficult during ‘Hell Week. ‘ You get 4 hours of sleep. You’re not allowed to have any caffeine. Throughout the entire week, you’re hungry, you’re cold, you’re sandy, you’re wet, just the lack of sleep.

What are the categories of non-sterile compounding?

There are 3 types of nonsterile compounding described in USP Chapter 795: simple, moderate and complex.

What is the difference between sterile and non-sterile compounding?

Sterile compounded medications are intended to be used as injections, infusions, or application to the eye. Non-sterile medications include the production of solutions, suspensions, ointments, creams, powders, suppositories, capsules, and tablets.

What is an immediate use CSP?

The immediate-use provision allows for the preparation and dispensing of compounded sterile products (CSPs) without the need to be in compliance with USP <797> requirements such as ISO Class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing.

Which is an example of a low-risk level CSP?

Low-risk compounding conditions It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution. Examples include: Simple withdrawal and transferring of not more than three sterile products (including diluents and solutions) to compound a final preparation.

What is a medium-risk compounding process?

If you compound or pool multiple doses of sterile products for administration to multiple patients or to a single patient on multiple occasions and the compounding process involves more than single-volume transfer or takes a long time (such as complete dissolution or homogenous mixing), the process will usually be considered medium-risk.

What is the risk level of the compounding process?

In USP 797 (2008), the risk level is defined primarily on the complexity of the compounding process. Fewer components for admixture or a lower level of product manipulation indicate low-risk conditions.

What is medium risk level compounding (MRL)?

Medium Risk Level Compounding: Products are compounded with aseptic manipulations entirely within an ISO Class 5 or better air quality device, usually within an ISO Class 7 environment, using sterile products, components, and devices.

What is low-risk compounding?

Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages. It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution. Examples include: