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Sterile Product Compounding: A Comparison of ASHP and USP Guidelines

Author(s):  Lima Hetty A

Issue:  Jul/Aug 1999 - Compounding Parenteral Products
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Abstract:  There are no professional standards of practice dealing with sterile products. The author discusses regulations, guideline scope (of the American Society of Hospital Pharmacists Technical Assistance Bulletin), guideline classification, and policy and procedures. Tables provide guideline content and provide comparisons/contrasts between the two sets of guidelines (the American Society of Hospital Pharmacists and the United States Pharmacopeial Convention). The author concludes that pharmacists who prepare sterile products should read both guidelines and determine the appropriate risk level of the sterile products they prepare. Pharmacists should ensure that the products they prepare are categorized into the appropriate category based upon multiple compounding breaks, complexity of compounding, high-risk administration sites and any extenuating circumstances. Professional judgment should be exercised when applying the guidelines to specific pharmacy practice settings to ensure the highest level of product quality.

Related Keywords: ASHP, Current Good Manufacturing Practices (cGMPs), FDA, guidelines, pharmacists, policy, procedures, regulations, risk levels, standard operating procedures, sterile products, USP


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