International journal of pharmaceutical compounding
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Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U. S. ⋯ Compounding pharmacists are expected to follow good preparation prodecures in their compounding practices in much the same way pharmaceutical manufacturers are required to follow Current Good Manufacturing Procedures as detailed in the United States Code of Federal Regulations. Application of Quality by Design concepts to the preparation process for a compounded medication can help in understanding the potential pitfalls and the means to mitigate their impact. The goal is to build quality into the compounding process to ensure that the resultant compounded prescription meets the human or animal patients' requirements.
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The need for continued improvement in pain management is growing. This review is aimed towards identifying the literature regarding clinical and therapeutic value of the commonly used ingredients in pain management compounds: lidocaine, tetracaine, ketoprofen, ketamine, and gabapentin. Prospectively, future studies should be conducted to identify the exact benefits and side effects of compounded pain management therapies, such that these compounds can be effectively utilized when deemed appropriate.
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The tragedy surrounding the New England Compounding Center and contaminated steroid syringe preparations clearly points out what can happen if quality-assurance and quality-control procedures are not strictly practiced in the compounding of sterile preparations. This article is part 2 of a two-part article on requirements to comply with United States Pharmacopeia general chapters <797> and <1163> with respect to quality assurance of compounded sterile preparations. Part 1 covered documentation requirements, inspection procedures, compounding accuracy checks, and part of a discussion on bacterial endotoxin testing. Part 2 covers sterility testing, the completion from part 1 on bacterial endotoxin testing, a brief dicussion of United States Pharmacopeia <1163>, and advances in pharmaceutical quality systems.
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Sterilization kills microorganisms in compounded preparations, on the implements used to prepare them, and on the vessels that contain them, but depyrogenation incinerates the remaining debris and renders the treated tool, container, or meditation pyrogen free. Depyrogenation is thus an essential step in the preparation of sterile compounds, and the pharmacist who dispenses those formulations is directly responsible for ensuring their safety, potency, and purity. Dry heat provided by a depyrogenation oven or tunnel is the pharmaceutical gold standard for ensuring the elimination of pyrogens. In this report, we describe several depyrogenation ovens that are compliant with Current Good Manufacturing Practice standards and are appropriate for use in aseptic-compounding facilities that meet the guidelines set forth in United States Pharmacopela Chapter <797>.
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There are serious consequences if contamination control is not enforced and contaminated products/preparations are released to the market. The greatest risk of microbial contamination is exposure of sterile (also termed "critical") sites to potential sources of contamination. Contamination control basically involves at least fourteen entities to control or that help to determine the extent (quality) of control. Some of these entities are covered in this article; others will be covered in subsequent articles by the author.