A Revision Bulletin for Yes, a strength (potency over time) test determines the amount of active ingredient in a preparation, however, it may not be able to separate the inactive ingredient from its degradation products and impurities for quantitation depending on the analytical methods used for the test.
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.
Category 1 CSPs have a shorter maximum beyond use date (BUD), while Category 2 CSPs have a longer maximum BUD, based on several factors, such as sterility considerations.
The revised chapter describes all the applicable standards for Category 1 and 2 CSPs.
Prior to its publication, there was little monetary or official support for pharmacies looking to improve their compounding processes, despite thousands of cases of septicemia from exposure to compounded intravenous (IV) from the 1970s on.
into state legislation and adoption of a policy of enforcement by the Joint Commission encouraged swift action and compliance on the part of hospitals and pharmacies across the country.
The chapter is divided into the following main sections: Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed.Generally, medium-risk CSPs do not have broad-spectrum bacteriostatic substances and are administered over multiple days. Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices.This presentation looks at the differences between a manufacturer's expiration date and a sterile compounds beyond-use date (BUD).While the safety of compounded sterile preparations (CSPs) has been an important topic in the practice of pharmacy for decades, the recent tragic deaths related to fungal contamination of preservative-free methylprednisolone injection have once again put the topic on the national stage.