Usp 797 beyond use dating guidelines cody wyoming dating

Beyond use dates are different from expiration dates.Expiration dates are required on commercially manufactured products and are determined after extensive study of the product's stability.A stability-indicating method will be able to quantitate the active ingredient and its degradation products or related impurities in the preparation by separating the inactive ingredient from its degradation products and impurities, and to show a change in the concentration of the active ingredient with increasing storage time.A stability-indicating method is used to determine stability of a drug and used to establish the Beyond-Use Date.Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients.The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.

Without performing a sterility test, CSPs should not be stored longer than 48 hours at a controlled room temperature, 14 days in refrigerated settings or 45 days if frozen solid at -20 degrees Fahrenheit or colder.The quality control and testing for CSPs in this chapter are appropriate and necessary.The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed.USP Chapter 797 sets compounding risk levels based on the likelihood of contaminating a compounded sterile preparation (CSP) with microorganisms, spores, endotoxins or other foreign material.Knowing the level of risk corresponding to each compounded preparation is important because different rules apply to the compounding process depending on the level of risk.Medium-risk conditions—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.

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