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Abstract:  United States Pharmacopeia Chapter <797> Pharmaceutical Compounding—Sterile Preparations pertains to all preadministration manipulations and procedures involved in preparation of sterile compounds for application, implantation, infusion, inhalation, injection, insertion, instillation, or irrigation, including preparation, storage, and transportation. The chapter does not pertain to actual clinical administration of compounded sterile preparations to patients. The intent of Chapter <797> is simply to prevent patient harm and fatalities that may result from nonsterility, excessive endotoxin load, large content errors in strength of correct ingredients, or the presence of incorrect ingredients. Because the achievement of sterility requires that facilities meet minimum cleanliness standards, that personnel be trained adequately and undergo periodic testing and training in sterilization techniques, and that appropriate principles and practices be applied to sustain solution stability, compliance to Chapter <797> should be the goal of any facility where sterile preparations are compounded. Many pharmacies have already become compliant with Chapter <797>, and those that have already met the new standards seem to support them strongly.

Related Keywords: Claudia C. Okeke, PhD, RPh, United States Pharmacopeia Chapter <797>, USP, compounded sterile preparations, standards, quality control, training, stability, quality assurance, Shelly J. Stockton, PhD, hydroxyprogesterone caproate, testosterone pellets, Loyd V. Allen, Jr., PhD, RPh

Related Categories: LEGAL, STERILE PREPARATIONS, QUALITY CONTROL, PHARMACY EDUCATION, UNITED STATES PHARMACOPEIA CONVENTIONS

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